Lumbar Disc Disease, Lumbar Osteoarthritis, Spinal Stenosis, Spondylosis
Conditions
Keywords
IV acetaminophen, IV Ketorolac, Post-operative analgesia, Opioid use
Brief summary
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects. The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function \[quicker ambulation with physical therapy (PT), earlier return to work, etc.\].
Detailed description
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows: * Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS) * Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.
Interventions
DRUGKetorolac
Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
DRUGAcetaminophen
Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
DRUGPlacebo
Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 * Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach * No history of long term opioid use (daily or almost daily opioid use \> 2 weeks) and not on opiates at time of presentation to clinic
Exclusion criteria
* Documented allergy to NSAIDs or Acetaminophen * History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine \> 1.5 mg/dL), Glucocorticoid use within 1 month of surgery * Current smokers (quite date \< 30 days ago) * Revision for pseudarthrosis * Patients who are unable to physically or mentally provide consent to the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Opioid Use | Hospital stay (2-4 days) | Measure the impact of treatment on total opioid use during the hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use at 3 Months | 3 months | Track opioid use after discharge for the first 3 months; assess for continued opioid use |
| Opioid Use at 1 Year | 1 year | Track opioid use after discharge for the first 1 year; assess for continued opioid use |
| Opioid Use at 2 Years | 2 years | Track total opioid use after discharge for the first 2 years; assess for continued opioid use |
| Numerical Pain Rating Scale | 1 days and 3 days | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level |
| Brief Pain Inventory | 1 day and 3 days | The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring. |
| Opioid Related Side Effects | Hospital Stay (1-4 days) | Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded |
| Opioid Use at 4-6 Weeks | 4-6 weeks | Track opioid use after discharge for the first 4-6 weeks |
| Perioperative Complications - Transfusion Rate | Hospital Stay (1-4 days) | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded |
| Days to Walk 50 ft With PT | Hospital Stay (1-4 days) | Days needed to be able to walk 50ft with PT |
| Length of Stay | Hospital Stay (1-4 days) | Will record date of discharge |
| Veterans Rand - 12 | pre-operative | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. |
| Oswestry Disability Index | pre-operative | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. |
| Return to Work | 3 month follow up | Record return to work |
| Perioperative Complications - Drain Output | Hospital Stay (1-4 days) | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded |
Countries
United States
Participant flow
Pre-assignment details
Assessed for eligibility (n= 1,372) Excluded (n= 1,194) * Not meeting inclusion criteria (n= 1,137) * Declined to participate (n= 132) * Other reasons (n= 103)
Participants by arm
| Arm | Count |
|---|---|
| IV Ketorolac IV Ketorolac arm
Ketorolac: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | 44 |
| Intravenous (IV) Placebo IV Placebo arm
Placebo: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | 43 |
| IV Acetaminophen IV Acetaminophen arm
Acetaminophen: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | 41 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Discontinued intervention | 14 | 15 | 14 |
| Overall Study | Protocol Violation | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | IV Ketorolac | Intravenous (IV) Placebo | IV Acetaminophen | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 11 Participants | 10 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 32 Participants | 31 Participants | 94 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 11.2 | 56.3 years STANDARD_DEVIATION 11.1 | 56.1 years STANDARD_DEVIATION 13.2 | 57.0 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 40 Participants | 39 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 44 participants | 43 participants | 41 participants | 128 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 20 Participants | 55 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants | 21 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 43 | 0 / 41 |
| other Total, other adverse events | 40 / 44 | 40 / 43 | 38 / 41 |
| serious Total, serious adverse events | 10 / 44 | 9 / 43 | 11 / 41 |
Outcome results
Primary
Perioperative Opioid Use
Measure the impact of treatment on total opioid use during the hospital stay
Time frame: Hospital stay (2-4 days)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IV Ketorolac | Perioperative Opioid Use | OME total in the first 72H | 86.25 oral morphine equivalents (OME) (mmg) |
| IV Ketorolac | Perioperative Opioid Use | OME total to discharge | 88.95 oral morphine equivalents (OME) (mmg) |
| Intravenous (IV) Placebo | Perioperative Opioid Use | OME total in the first 72H | 306.6 oral morphine equivalents (OME) (mmg) |
| Intravenous (IV) Placebo | Perioperative Opioid Use | OME total to discharge | 324 oral morphine equivalents (OME) (mmg) |
| IV Acetaminophen | Perioperative Opioid Use | OME total in the first 72H | 192.4 oral morphine equivalents (OME) (mmg) |
| IV Acetaminophen | Perioperative Opioid Use | OME total to discharge | 237.9 oral morphine equivalents (OME) (mmg) |
Comparison: The distribution of OME total in the first 72H is the same across these armsp-value: <0.001Kruskal-Wallis
Comparison: The distribution of OME total to discharge is the same across these armsp-value: <0.001Kruskal-Wallis
Secondary
Brief Pain Inventory
The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring.
Time frame: 1 day and 3 days
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with Normal work | 9 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with Sleep | 3 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with Walking Ability | 5 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with Walking Ability | 5 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with Enjoyment of life | 5 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with Mood | 2 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with Mood | 5 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with General Activity | 8 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with Relation with other | 2 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with Normal work | 8 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with Enjoyment of life | 7 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with General Activity | 6.5 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD1 - Pain has interfered with Relation with other | 0 score on a scale |
| IV Ketorolac | Brief Pain Inventory | POD3 - Pain has interfered with Sleep | 6 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with Normal work | 10 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with General Activity | 9 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with Mood | 4 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with Walking Ability | 7 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with Normal work | 10 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with Relation with other | 2.5 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with Sleep | 5 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD1 - Pain has interfered with Enjoyment of life | 9 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with General Activity | 7 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with Mood | 3 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with Walking Ability | 4.5 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with Relation with other | 2 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with Sleep | 4 score on a scale |
| Intravenous (IV) Placebo | Brief Pain Inventory | POD3 - Pain has interfered with Enjoyment of life | 6.5 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with Sleep | 5 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with Walking Ability | 6 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with Relation with other | 1.5 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with Normal work | 8 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with Normal work | 8 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with Walking Ability | 7 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with General Activity | 9 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with Relation with other | 4 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with Mood | 1.5 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with General Activity | 8 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with Enjoyment of life | 7 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with Enjoyment of life | 8 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD3 - Pain has interfered with Mood | 5 score on a scale |
| IV Acetaminophen | Brief Pain Inventory | POD1 - Pain has interfered with Sleep | 6 score on a scale |
Comparison: The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 armsp-value: 0.016Kruskal-Wallis
Comparison: The distribution of POD1 - Pain has interfered with Mood is the same across the 3 armsp-value: 0.294Kruskal-Wallis
Comparison: The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 armsp-value: 0.016Kruskal-Wallis
Comparison: The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 armsp-value: 0.082Kruskal-Wallis
Comparison: The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 armsp-value: 0.117Kruskal-Wallis
Comparison: The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 armsp-value: 0.061Fisher Exact
Comparison: The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 armsp-value: 0.023Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 armsp-value: 0.681Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with Mood is the same across the 3 armsp-value: 0.405Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 armsp-value: 0.458Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 armsp-value: 0.482Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 armsp-value: 0.544Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 armsp-value: 0.202Kruskal-Wallis
Comparison: The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 armsp-value: 0.58Kruskal-Wallis
Secondary
Days to Walk 50 ft With PT
Days needed to be able to walk 50ft with PT
Time frame: Hospital Stay (1-4 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Days to Walk 50 ft With PT | POD1 | 11 Participants |
| IV Ketorolac | Days to Walk 50 ft With PT | POD0 | 30 Participants |
| IV Ketorolac | Days to Walk 50 ft With PT | POD2 and after | 3 Participants |
| Intravenous (IV) Placebo | Days to Walk 50 ft With PT | POD1 | 12 Participants |
| Intravenous (IV) Placebo | Days to Walk 50 ft With PT | POD0 | 26 Participants |
| Intravenous (IV) Placebo | Days to Walk 50 ft With PT | POD2 and after | 5 Participants |
| IV Acetaminophen | Days to Walk 50 ft With PT | POD0 | 24 Participants |
| IV Acetaminophen | Days to Walk 50 ft With PT | POD2 and after | 3 Participants |
| IV Acetaminophen | Days to Walk 50 ft With PT | POD1 | 14 Participants |
p-value: 792Chi-squared
Secondary
Length of Stay
Will record date of discharge
Time frame: Hospital Stay (1-4 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Ketorolac | Length of Stay | 49.5 Hour |
| Intravenous (IV) Placebo | Length of Stay | 77 Hour |
| IV Acetaminophen | Length of Stay | 70 Hour |
Comparison: The distribution of Length of stay in day is the same across these armsp-value: 0.034Kruskal-Wallis
Comparison: The distribution of Length of stay in hour is the same across these armsp-value: 0.03Kruskal-Wallis
Secondary
Numerical Pain Rating Scale
Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level
Time frame: 2 year follow up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IV Ketorolac | Numerical Pain Rating Scale | 2 year - Best pain level | 1 score on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | 2 year - Current pain level | 4 score on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | 2 year - Worst pain level | 13 score on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | 2 year - Best pain level | 0 score on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | 2 year - Current pain level | 3 score on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | 2 year - Worst pain level | 1.5 score on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | 2 year - Current pain level | 12.5 score on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | 2 year - Worst pain level | 18 score on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | 2 year - Best pain level | 8.5 score on a scale |
Secondary
Numerical Pain Rating Scale
Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level
Time frame: 1 days and 3 days
Population: Analysis performed on patient with data completed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IV Ketorolac | Numerical Pain Rating Scale | POD3 - Worst pain level | 84 units on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | POD1 - Worst pain level | 62 units on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | PDO3 - Best pain level | 23 units on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | POD1 - Current pain level | 39 units on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | POD3 - Current pain level | 66 units on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | POD1 - Best pain level | 23 units on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | POD3 - Current pain level | 47 units on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | PDO3 - Best pain level | 25 units on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | POD1 - Best pain level | 24.5 units on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | POD3 - Worst pain level | 83 units on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | POD1 - Current pain level | 46 units on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | POD1 - Worst pain level | 89.5 units on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | POD1 - Worst pain level | 74 units on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | POD1 - Current pain level | 42 units on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | POD1 - Best pain level | 21 units on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | POD3 - Worst pain level | 72.5 units on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | POD3 - Current pain level | 52 units on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | PDO3 - Best pain level | 39 units on a scale |
Comparison: The distribution of POD1 - Current pain level is the same across the 3 armsp-value: 0.732Kruskal-Wallis
Comparison: The distribution of POD1 - Best pain level is the same across the 3 armsp-value: 0.896Kruskal-Wallis
Comparison: The distribution of POD1 - Worst pain level is the same across the 3 armsp-value: 0.004Kruskal-Wallis
Comparison: The distribution of POD3 - Current pain level is the same across the 3 armsp-value: 0.325Kruskal-Wallis
Comparison: The distribution of POD3 - Best pain level is the same across the 3 armsp-value: 0.283Kruskal-Wallis
Comparison: The distribution of POD3 - Worst pain level is the same across the 3 armsp-value: 0.61Kruskal-Wallis
Secondary
Numerical Pain Rating Scale
Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level
Time frame: 1 year follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IV Ketorolac | Numerical Pain Rating Scale | 1-year - Worst pain level | 11 score on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | 1-year - Current pain level | 6 score on a scale |
| IV Ketorolac | Numerical Pain Rating Scale | 1-year - Best pain level | 4 score on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | 1-year - Worst pain level | 8 score on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | 1-year - Current pain level | 7 score on a scale |
| Intravenous (IV) Placebo | Numerical Pain Rating Scale | 1-year - Best pain level | 0 score on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | 1-year - Worst pain level | 25 score on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | 1-year - Best pain level | 9 score on a scale |
| IV Acetaminophen | Numerical Pain Rating Scale | 1-year - Current pain level | 13 score on a scale |
Secondary
Opioid Related Side Effects
Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded
Time frame: Hospital Stay (1-4 days)
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| IV Ketorolac | Opioid Related Side Effects | POD1 - Lightheaded or dizzy? | Yes | 24 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Nausea? | No | 28 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Vomiting? | Yes | 1 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Vomiting? | No | 43 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Constipation? | Yes | 19 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Constipation? | No | 25 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Difficulty passing urine? | Yes | 11 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Difficulty passing urine? | No | 33 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Difficulty concentrating? | Yes | 14 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Difficulty concentrating? | No | 30 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Drowsiness/Difficulty Staying Awake? | Yes | 21 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Drowsiness/Difficulty Staying Awake? | No | 23 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Nausea? | Yes | 16 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Lightheaded or dizzy? | No | 20 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Feeling confused? | Yes | 4 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Feeling confused? | No | 40 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Fatigue? | Yes | 17 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Fatigue? | No | 27 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Itchiness? | Yes | 9 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Itchiness? | No | 35 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Dry mouth? | Yes | 33 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Dry mouth? | No | 11 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Headache? | Yes | 5 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD1 - Headache? | No | 38 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Nausea? | Yes | 10 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Nausea? | No | 26 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Vomiting? | Yes | 2 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Vomiting? | No | 34 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Constipation? | Yes | 21 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Constipation? | No | 15 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Difficulty passing urine? | Yes | 5 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Difficulty passing urine? | No | 31 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Difficulty concentrating? | Yes | 16 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Difficulty concentrating? | No | 20 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Drowsiness/Difficulty Staying Awake? | Yes | 20 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Drowsiness/Difficulty Staying Awake? | No | 15 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Lightheaded or dizzy? | Yes | 10 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Lightheaded or dizzy? | No | 26 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Feeling confused? | Yes | 5 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Feeling confused? | No | 31 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Fatigue? | Yes | 23 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Fatigue? | No | 13 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Itchiness? | Yes | 13 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Itchiness? | No | 23 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Dry mouth? | Yes | 24 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Dry mouth? | No | 12 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Headache? | Yes | 7 Participants |
| IV Ketorolac | Opioid Related Side Effects | POD3 - Headache? | No | 29 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Lightheaded or dizzy? | No | 28 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Fatigue? | Yes | 23 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Fatigue? | No | 17 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Itchiness? | Yes | 14 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Feeling confused? | Yes | 4 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Itchiness? | No | 26 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Dry mouth? | Yes | 36 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Dry mouth? | No | 4 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Feeling confused? | No | 32 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Headache? | Yes | 6 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Headache? | No | 34 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Dry mouth? | No | 17 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Nausea? | Yes | 12 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Fatigue? | Yes | 24 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Nausea? | No | 24 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Vomiting? | Yes | 1 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Vomiting? | No | 35 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Fatigue? | No | 12 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Constipation? | Yes | 22 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Constipation? | No | 14 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Headache? | No | 25 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Difficulty passing urine? | Yes | 5 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Itchiness? | Yes | 13 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Difficulty passing urine? | No | 31 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Nausea? | Yes | 17 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Difficulty concentrating? | Yes | 19 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Nausea? | No | 23 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Vomiting? | Yes | 5 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Headache? | Yes | 11 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Vomiting? | No | 35 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Difficulty concentrating? | No | 17 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Constipation? | Yes | 18 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Constipation? | No | 22 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Itchiness? | No | 23 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Difficulty passing urine? | Yes | 13 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Drowsiness/Difficulty Staying Awake? | Yes | 25 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Difficulty passing urine? | No | 27 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Difficulty concentrating? | Yes | 18 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Difficulty concentrating? | No | 22 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Drowsiness/Difficulty Staying Awake? | No | 11 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Drowsiness/Difficulty Staying Awake? | Yes | 25 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Drowsiness/Difficulty Staying Awake? | No | 15 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Lightheaded or dizzy? | Yes | 21 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Lightheaded or dizzy? | Yes | 8 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Lightheaded or dizzy? | No | 19 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Feeling confused? | Yes | 8 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD3 - Dry mouth? | Yes | 19 Participants |
| Intravenous (IV) Placebo | Opioid Related Side Effects | POD1 - Feeling confused? | No | 32 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Itchiness? | Yes | 10 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Drowsiness/Difficulty Staying Awake? | Yes | 18 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Fatigue? | Yes | 20 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Lightheaded or dizzy? | No | 22 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Nausea? | Yes | 17 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Fatigue? | No | 18 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Dry mouth? | Yes | 20 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Lightheaded or dizzy? | Yes | 8 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Itchiness? | Yes | 13 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Difficulty concentrating? | Yes | 12 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Nausea? | No | 21 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Itchiness? | No | 25 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Feeling confused? | Yes | 2 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Difficulty concentrating? | Yes | 13 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Dry mouth? | Yes | 29 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Headache? | No | 20 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Itchiness? | No | 20 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Dry mouth? | No | 9 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Vomiting? | Yes | 5 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Lightheaded or dizzy? | Yes | 18 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Headache? | Yes | 3 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Feeling confused? | No | 28 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Difficulty concentrating? | No | 24 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Headache? | No | 35 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Vomiting? | No | 32 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Feeling confused? | No | 34 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Nausea? | Yes | 5 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Feeling confused? | Yes | 3 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Constipation? | Yes | 7 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Nausea? | No | 25 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Fatigue? | Yes | 18 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Difficulty concentrating? | No | 17 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Vomiting? | Yes | 2 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Dry mouth? | No | 10 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Drowsiness/Difficulty Staying Awake? | Yes | 21 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Vomiting? | No | 28 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Constipation? | No | 31 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Drowsiness/Difficulty Staying Awake? | No | 12 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Constipation? | Yes | 15 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Fatigue? | No | 12 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Lightheaded or dizzy? | No | 19 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Constipation? | No | 15 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Difficulty passing urine? | Yes | 5 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Drowsiness/Difficulty Staying Awake? | No | 17 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Difficulty passing urine? | Yes | 3 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Headache? | Yes | 10 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD1 - Difficulty passing urine? | No | 32 Participants |
| IV Acetaminophen | Opioid Related Side Effects | POD3 - Difficulty passing urine? | No | 27 Participants |
Secondary
Opioid Use at 1 Year
Track opioid use after discharge for the first 1 year; assess for continued opioid use
Time frame: 1 year
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Opioid Use at 1 Year | No opioid use | 32 Participants |
| IV Ketorolac | Opioid Use at 1 Year | Opioid use | 1 Participants |
| Intravenous (IV) Placebo | Opioid Use at 1 Year | No opioid use | 31 Participants |
| Intravenous (IV) Placebo | Opioid Use at 1 Year | Opioid use | 0 Participants |
| IV Acetaminophen | Opioid Use at 1 Year | No opioid use | 21 Participants |
| IV Acetaminophen | Opioid Use at 1 Year | Opioid use | 1 Participants |
Secondary
Opioid Use at 2 Years
Track total opioid use after discharge for the first 2 years; assess for continued opioid use
Time frame: 2 years
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Opioid Use at 2 Years | No opioid use | 26 Participants |
| IV Ketorolac | Opioid Use at 2 Years | Opioid use | 1 Participants |
| Intravenous (IV) Placebo | Opioid Use at 2 Years | No opioid use | 26 Participants |
| Intravenous (IV) Placebo | Opioid Use at 2 Years | Opioid use | 1 Participants |
| IV Acetaminophen | Opioid Use at 2 Years | No opioid use | 22 Participants |
| IV Acetaminophen | Opioid Use at 2 Years | Opioid use | 3 Participants |
Secondary
Opioid Use at 3 Months
Track opioid use after discharge for the first 3 months; assess for continued opioid use
Time frame: 3 months
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Opioid Use at 3 Months | No opioid use | 32 Participants |
| IV Ketorolac | Opioid Use at 3 Months | Opioid use | 5 Participants |
| Intravenous (IV) Placebo | Opioid Use at 3 Months | No opioid use | 25 Participants |
| Intravenous (IV) Placebo | Opioid Use at 3 Months | Opioid use | 2 Participants |
| IV Acetaminophen | Opioid Use at 3 Months | No opioid use | 26 Participants |
| IV Acetaminophen | Opioid Use at 3 Months | Opioid use | 5 Participants |
p-value: 0.595Chi-squared
Secondary
Opioid Use at 4-6 Weeks
Track opioid use after discharge for the first 4-6 weeks
Time frame: 4-6 weeks
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Opioid Use at 4-6 Weeks | No opioid use | 34 Participants |
| IV Ketorolac | Opioid Use at 4-6 Weeks | Opioid use | 9 Participants |
| Intravenous (IV) Placebo | Opioid Use at 4-6 Weeks | No opioid use | 33 Participants |
| Intravenous (IV) Placebo | Opioid Use at 4-6 Weeks | Opioid use | 6 Participants |
| IV Acetaminophen | Opioid Use at 4-6 Weeks | No opioid use | 22 Participants |
| IV Acetaminophen | Opioid Use at 4-6 Weeks | Opioid use | 14 Participants |
Comparison: Similar Distribution of opioid use between the 3 armsp-value: 0.048Chi-squared
Secondary
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Time frame: 2 year follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ketorolac | Oswestry Disability Index | 14.7 percentage | Standard Deviation 14.5 |
| Intravenous (IV) Placebo | Oswestry Disability Index | 11.4 percentage | Standard Deviation 11.6 |
| IV Acetaminophen | Oswestry Disability Index | 16.0 percentage | Standard Deviation 15.1 |
Secondary
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Time frame: pre-operative
Population: Patient treated Per-Protocol with pre-operative ODI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ketorolac | Oswestry Disability Index | 36.3 percentage | Standard Deviation 14.3 |
| Intravenous (IV) Placebo | Oswestry Disability Index | 35.4 percentage | Standard Deviation 11.1 |
| IV Acetaminophen | Oswestry Disability Index | 40.6 percentage | Standard Deviation 15.9 |
p-value: 0.215ANOVA
Secondary
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Time frame: 1 year follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ketorolac | Oswestry Disability Index | 16.9 percentage | Standard Deviation 15.7 |
| Intravenous (IV) Placebo | Oswestry Disability Index | 12.1 percentage | Standard Deviation 13.3 |
| IV Acetaminophen | Oswestry Disability Index | 17.8 percentage | Standard Deviation 14.2 |
Secondary
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Time frame: 3 month follow up
Population: patient treated Per-Protocol with completed follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Ketorolac | Oswestry Disability Index | 22.8 percentage | Standard Deviation 15.7 |
| Intravenous (IV) Placebo | Oswestry Disability Index | 18.8 percentage | Standard Deviation 12.9 |
| IV Acetaminophen | Oswestry Disability Index | 25.0 percentage | Standard Deviation 13.6 |
p-value: 0.191ANOVA
Secondary
Perioperative Complications - Drain Output
Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded
Time frame: Hospital Stay (1-4 days)
Population: Patient treated Per-Protocol with completed data
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IV Ketorolac | Perioperative Complications - Drain Output | Total Drain output 24H | 270 mL |
| IV Ketorolac | Perioperative Complications - Drain Output | Total Drain output 48H | 390 mL |
| IV Ketorolac | Perioperative Complications - Drain Output | Total Drain output 72H | 390 mL |
| IV Ketorolac | Perioperative Complications - Drain Output | Total Drain output at discharge | 390 mL |
| Intravenous (IV) Placebo | Perioperative Complications - Drain Output | Total Drain output at discharge | 335 mL |
| Intravenous (IV) Placebo | Perioperative Complications - Drain Output | Total Drain output 24H | 235 mL |
| Intravenous (IV) Placebo | Perioperative Complications - Drain Output | Total Drain output 72H | 335 mL |
| Intravenous (IV) Placebo | Perioperative Complications - Drain Output | Total Drain output 48H | 305 mL |
| IV Acetaminophen | Perioperative Complications - Drain Output | Total Drain output at discharge | 340 mL |
| IV Acetaminophen | Perioperative Complications - Drain Output | Total Drain output 48H | 320 mL |
| IV Acetaminophen | Perioperative Complications - Drain Output | Total Drain output 72H | 340 mL |
| IV Acetaminophen | Perioperative Complications - Drain Output | Total Drain output 24H | 240 mL |
Comparison: The distribution of Total Drain output at 24H is the same across the 3 armsp-value: 0.928Kruskal-Wallis
Comparison: The distribution of Total Drain output at 48H is the same across the 3 armsp-value: 0.906Kruskal-Wallis
Comparison: The distribution of Total Drain output at 72H is the same across the 3 armsp-value: 0.926Kruskal-Wallis
Comparison: The distribution of Total Drain output at Discharge is the same across the 3 armsp-value: 0.934Kruskal-Wallis
Secondary
Perioperative Complications - Transfusion Rate
Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded
Time frame: Hospital Stay (1-4 days)
Population: Patient treated Per-Protocol with completed data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Perioperative Complications - Transfusion Rate | No transfusion | 40 Participants |
| IV Ketorolac | Perioperative Complications - Transfusion Rate | Transfusion | 4 Participants |
| Intravenous (IV) Placebo | Perioperative Complications - Transfusion Rate | No transfusion | 42 Participants |
| Intravenous (IV) Placebo | Perioperative Complications - Transfusion Rate | Transfusion | 1 Participants |
| IV Acetaminophen | Perioperative Complications - Transfusion Rate | No transfusion | 41 Participants |
| IV Acetaminophen | Perioperative Complications - Transfusion Rate | Transfusion | 0 Participants |
Comparison: Proportion of patient receiving at least 1 transfusion is the same across the 3 armsp-value: 0.078Chi-squared
Secondary
Return to Work
Record return to work
Time frame: 3 month follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Return to Work | Does not Apply | 9 Participants |
| IV Ketorolac | Return to Work | Lighter job | 3 Participants |
| IV Ketorolac | Return to Work | Complete disability | 3 Participants |
| IV Ketorolac | Return to Work | Original job, full time | 15 Participants |
| IV Ketorolac | Return to Work | Original job. part time | 4 Participants |
| IV Ketorolac | Return to Work | Early retirement | 1 Participants |
| Intravenous (IV) Placebo | Return to Work | Complete disability | 5 Participants |
| Intravenous (IV) Placebo | Return to Work | Original job, full time | 12 Participants |
| Intravenous (IV) Placebo | Return to Work | Does not Apply | 7 Participants |
| Intravenous (IV) Placebo | Return to Work | Early retirement | 0 Participants |
| Intravenous (IV) Placebo | Return to Work | Lighter job | 3 Participants |
| Intravenous (IV) Placebo | Return to Work | Original job. part time | 3 Participants |
| IV Acetaminophen | Return to Work | Original job. part time | 3 Participants |
| IV Acetaminophen | Return to Work | Lighter job | 0 Participants |
| IV Acetaminophen | Return to Work | Does not Apply | 7 Participants |
| IV Acetaminophen | Return to Work | Original job, full time | 20 Participants |
| IV Acetaminophen | Return to Work | Complete disability | 1 Participants |
| IV Acetaminophen | Return to Work | Early retirement | 2 Participants |
Secondary
Return to Work
Record return to work
Time frame: 2 year follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Return to Work | Original job, part time | 3 Participants |
| IV Ketorolac | Return to Work | Complete disability | 0 Participants |
| IV Ketorolac | Return to Work | Original job, full time | 12 Participants |
| IV Ketorolac | Return to Work | Does not Apply | 5 Participants |
| IV Ketorolac | Return to Work | Lighter job | 0 Participants |
| IV Ketorolac | Return to Work | Early retirement | 5 Participants |
| Intravenous (IV) Placebo | Return to Work | Lighter job | 0 Participants |
| Intravenous (IV) Placebo | Return to Work | Original job, part time | 2 Participants |
| Intravenous (IV) Placebo | Return to Work | Early retirement | 5 Participants |
| Intravenous (IV) Placebo | Return to Work | Original job, full time | 9 Participants |
| Intravenous (IV) Placebo | Return to Work | Does not Apply | 8 Participants |
| Intravenous (IV) Placebo | Return to Work | Complete disability | 0 Participants |
| IV Acetaminophen | Return to Work | Original job, full time | 15 Participants |
| IV Acetaminophen | Return to Work | Does not Apply | 7 Participants |
| IV Acetaminophen | Return to Work | Early retirement | 3 Participants |
| IV Acetaminophen | Return to Work | Complete disability | 1 Participants |
| IV Acetaminophen | Return to Work | Lighter job | 0 Participants |
| IV Acetaminophen | Return to Work | Original job, part time | 0 Participants |
Secondary
Return to Work
Record return to work
Time frame: 1 year follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IV Ketorolac | Return to Work | Does not Apply | 9 Participants |
| IV Ketorolac | Return to Work | Early retirement | 3 Participants |
| IV Ketorolac | Return to Work | Complete disability | 0 Participants |
| IV Ketorolac | Return to Work | Lighter job | 1 Participants |
| IV Ketorolac | Return to Work | Original job, part time | 2 Participants |
| IV Ketorolac | Return to Work | Original job, full time | 17 Participants |
| Intravenous (IV) Placebo | Return to Work | Original job, full time | 16 Participants |
| Intravenous (IV) Placebo | Return to Work | Does not Apply | 7 Participants |
| Intravenous (IV) Placebo | Return to Work | Lighter job | 1 Participants |
| Intravenous (IV) Placebo | Return to Work | Original job, part time | 2 Participants |
| Intravenous (IV) Placebo | Return to Work | Early retirement | 3 Participants |
| Intravenous (IV) Placebo | Return to Work | Complete disability | 0 Participants |
| IV Acetaminophen | Return to Work | Early retirement | 4 Participants |
| IV Acetaminophen | Return to Work | Complete disability | 1 Participants |
| IV Acetaminophen | Return to Work | Original job, full time | 16 Participants |
| IV Acetaminophen | Return to Work | Lighter job | 0 Participants |
| IV Acetaminophen | Return to Work | Does not Apply | 3 Participants |
| IV Acetaminophen | Return to Work | Original job, part time | 0 Participants |
Secondary
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS.
Time frame: pre-operative
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ketorolac | Veterans Rand - 12 | PCS score | 34.7 score on a scale | Standard Deviation 10.8 |
| IV Ketorolac | Veterans Rand - 12 | MCS Score | 43.9 score on a scale | Standard Deviation 6.1 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | PCS score | 34.2 score on a scale | Standard Deviation 10.7 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | MCS Score | 42.9 score on a scale | Standard Deviation 6.7 |
| IV Acetaminophen | Veterans Rand - 12 | PCS score | 34.5 score on a scale | Standard Deviation 9.7 |
| IV Acetaminophen | Veterans Rand - 12 | MCS Score | 42.0 score on a scale | Standard Deviation 7.1 |
Comparison: Comparison of the PCS score between the 3 armsp-value: 0.974ANOVA
Comparison: Comparison of the MCS between the 3 amsp-value: 0.444ANOVA
Secondary
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS.
Time frame: 2 year follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ketorolac | Veterans Rand - 12 | PCS score | 46.6 score on a scale | Standard Deviation 10.7 |
| IV Ketorolac | Veterans Rand - 12 | MCS score | 46.4 score on a scale | Standard Deviation 5.8 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | PCS score | 51.2 score on a scale | Standard Deviation 9.1 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | MCS score | 44.5 score on a scale | Standard Deviation 4.9 |
| IV Acetaminophen | Veterans Rand - 12 | PCS score | 51.1 score on a scale | Standard Deviation 9.6 |
| IV Acetaminophen | Veterans Rand - 12 | MCS score | 46.7 score on a scale | Standard Deviation 3.8 |
Secondary
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS.
Time frame: 3 month follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ketorolac | Veterans Rand - 12 | PCS score | 43.1 score on a scale | Standard Deviation 11.8 |
| IV Ketorolac | Veterans Rand - 12 | MCS score | 45.0 score on a scale | Standard Deviation 5.3 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | PCS score | 48.7 score on a scale | Standard Deviation 8.8 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | MCS score | 44.3 score on a scale | Standard Deviation 6.1 |
| IV Acetaminophen | Veterans Rand - 12 | PCS score | 42.3 score on a scale | Standard Deviation 9.9 |
| IV Acetaminophen | Veterans Rand - 12 | MCS score | 45.3 score on a scale | Standard Deviation 4.5 |
Comparison: Comparison PCS score between the 3 armsp-value: 0.044ANOVA
Comparison: Comparison MCS score between the 3 armsp-value: 0.767ANOVA
Secondary
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS.
Time frame: 1 year follow up
Population: Patient treated Per-Protocol with completed follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Ketorolac | Veterans Rand - 12 | PCS score | 48.1 score on a scale | Standard Deviation 11.6 |
| IV Ketorolac | Veterans Rand - 12 | MCS score | 42.8 score on a scale | Standard Deviation 5.7 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | PCS score | 47.6 score on a scale | Standard Deviation 11.9 |
| Intravenous (IV) Placebo | Veterans Rand - 12 | MCS score | 45.0 score on a scale | Standard Deviation 6.7 |
| IV Acetaminophen | Veterans Rand - 12 | PCS score | 48.4 score on a scale | Standard Deviation 11.1 |
| IV Acetaminophen | Veterans Rand - 12 | MCS score | 45.3 score on a scale | Standard Deviation 4.4 |