Hip Injuries
Conditions
Keywords
Hip Arthroscopy, Opiate Use
Brief summary
The purpose of the study is to determine if opiates are required to achieve appropriate analgesia after hip arthroscopy in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic
Detailed description
Perioperative pain management is an important aspect of quality patient care. Opioid pain medications are increasingly being used for pain control, with the United States writing over 250 million prescriptions for painkillers per year. Increased usage has led to unintended negative consequences for individuals and society. It is estimated that 46 people die each day from an overdose of prescription painkillers, and individual use can lead to the development of tolerance and worse treatment outcomes. Further issues arise when opioids are misused, it is estimated that nontherapeutic use has increased three fold in recent years. In the United States alone in 2006 the estimated total cost of opioid prescription misuse was $53.4 billion, of which $42 billion was attributed to lost productivity, $8.2 billion to criminal justice cost and the remainder drug abuse treatment and medical complications. The federal government has recognized this epidemic and raised a call for clinicians to more responsibly prescribe opiate pain medications Opiate use has increased in recent years, from 2000-2010 the use of opiates in office based visits nearly doubled from 11.3% to 19.6% whereas there was no change in the prescribing of non-opioid pharmacotherapies. Further, when specifically looking at new musculoskeletal pain visits, one half resulted in pharmacologic treatment, with the prescribing of non-opioid pharmacotherapies decreasing from 38% to 29% from 2000 to 2010, respectively. The clinical use of opioids for post-operative pain control has also been linked to the opioid epidemic and risk of future abuse. Legitimate opioid use before high school graduation is independently associated with a 33% increased risk of future misuse after high school. It has been estimated that orthopedic surgeons prescribe 7.7% of all opioids in the United States.Special attention needs to be paid to the amount of opioid pain medications orthopedic surgeons prescribe to patients after ambulatory surgery, there is considerable variability among surgeon and procedure in regards to the amount of opioids to prescribe with many patients left with excess unused medication .An analysis of 250 patients undergoing outpatient upper extremity surgery found that on average patients consumed 10 opioid pills, with 19 pills left over and a total of 4,639 pills going unused in the cohort. Leftover prescription opioids are at risk for diversion to family and friends for nonmedical use. Further studies are needed to quantify the amount of opioids to prescribe for specific orthopedic procedures to limit excess narcotic use, misuse, diversion and contribution to the opioid epidemic.
Interventions
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Sponsors
Study design
Eligibility
Inclusion criteria
* All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy * 18 years old or greater * Ability to read and speak English
Exclusion criteria
* Revision surgery * Oncologic etiology * Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening * Patients with a current indication of narcotic use * Individuals unable to provide informed consent: * Prisoners * Pregnant women * Minors/Individuals under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) Pain Scores | Baseline (pre-operative) | minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient |
| Opiates Taken | 24 hours post-operative | Number of prescribed narcotic pills taken in the preceding time period |
| Opiates Remaining | 24 hours post-operative | Number of prescribed narcotic medication tablets remaining from initial amount prescribed |
| Date of Last Opiate Taken | 21 days post-operative | Days following surgery that the most recent dose of narcotic medication was taken |
| Number of Participants Reporting Side Effects | 24 hours postoperatively | As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - Hip Arthroscopy Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens. | 52 |
| Group 2 - Hip Arthroscopy Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens. | 59 |
| Total | 111 |
Baseline characteristics
| Characteristic | Group 1 - Hip Arthroscopy | Group 2 - Hip Arthroscopy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 59 Participants | 111 Participants |
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 11.2 | 36.9 Years STANDARD_DEVIATION 11.8 | 37.3 Years STANDARD_DEVIATION 11.5 |
| Are you an active smoker? No | 50 Participants | 57 Participants | 107 Participants |
| Are you an active smoker? Yes | 2 Participants | 2 Participants | 4 Participants |
| Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)? No | 51 Participants | 59 Participants | 110 Participants |
| Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)? Yes | 1 Participants | 0 Participants | 1 Participants |
| Body Mass Index | 26.2 kg/m2 STANDARD_DEVIATION 5.5 | 27.8 kg/m2 STANDARD_DEVIATION 6.1 | 27.1 kg/m2 STANDARD_DEVIATION 5.9 |
| Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)? No | 43 Participants | 51 Participants | 94 Participants |
| Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)? Yes | 9 Participants | 8 Participants | 17 Participants |
| Do you have a personal history of illicit substance abuse? No | 51 Participants | 59 Participants | 110 Participants |
| Do you have a personal history of illicit substance abuse? Yes | 1 Participants | 0 Participants | 1 Participants |
| If no, have you ever consistently smoked cigarettes (daily for > 1 month)? No | 46 Participants | 49 Participants | 95 Participants |
| If no, have you ever consistently smoked cigarettes (daily for > 1 month)? Yes | 6 Participants | 10 Participants | 16 Participants |
| Is this injury part of a workers compensation claim? No | 51 Participants | 58 Participants | 109 Participants |
| Is this injury part of a workers compensation claim? Yes | 1 Participants | 1 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 35 Participants | 73 Participants |
| Sex: Female, Male Male | 14 Participants | 24 Participants | 38 Participants |
| What is the highest level of education you attained? Completed High School | 5 Participants | 12 Participants | 17 Participants |
| What is the highest level of education you attained? Graduate | 16 Participants | 17 Participants | 33 Participants |
| What is the highest level of education you attained? Undergraduate | 31 Participants | 30 Participants | 61 Participants |
| What is your average yearly household income? $100,000 -$149,999 | 11 Participants | 8 Participants | 19 Participants |
| What is your average yearly household income? $150,000 - $199,999 | 6 Participants | 10 Participants | 16 Participants |
| What is your average yearly household income? $200,000 or more | 12 Participants | 12 Participants | 24 Participants |
| What is your average yearly household income? $20,000 -$34,999 | 1 Participants | 3 Participants | 4 Participants |
| What is your average yearly household income? $35,000 -$49,999 | 4 Participants | 5 Participants | 9 Participants |
| What is your average yearly household income? $50,000 -$74,999 | 5 Participants | 8 Participants | 13 Participants |
| What is your average yearly household income? $75,000 - $99,999 | 8 Participants | 10 Participants | 18 Participants |
| What is your average yearly household income? Less than $20,000 | 4 Participants | 3 Participants | 7 Participants |
| What is your average yearly household income? missing | 1 Participants | 0 Participants | 1 Participants |
| What is your employment status? Disabled | 2 Participants | 0 Participants | 2 Participants |
| What is your employment status? Employed | 39 Participants | 48 Participants | 87 Participants |
| What is your employment status? Unemployed | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 59 |
| other Total, other adverse events | 0 / 52 | 0 / 59 |
| serious Total, serious adverse events | 0 / 52 | 0 / 59 |
Outcome results
Date of Last Opiate Taken
Days following surgery that the most recent dose of narcotic medication was taken
Time frame: 21 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Date of Last Opiate Taken | 5.0 days | Standard Deviation 4.9 |
| Group 2 (30) - Hip Arthroscopy | Date of Last Opiate Taken | 4.6 days | Standard Deviation 5.8 |
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting
Time frame: 24 hours postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 16 Participants |
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 31 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 18 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 35 Participants |
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Time frame: 21 days postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 9 Participants |
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 38 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 7 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 46 Participants |
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Time frame: 7 days postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 10 Participants |
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 37 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 8 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 45 Participants |
Number of Participants Reporting Side Effects
As reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Time frame: 48 hours postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 15 Participants |
| Group 1 (60) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 32 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | Yes | 14 Participants |
| Group 2 (30) - Hip Arthroscopy | Number of Participants Reporting Side Effects | No | 39 Participants |
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time frame: 24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 3.9 score on a scale | Standard Deviation 2.5 |
| Group 2 (30) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 3.8 score on a scale | Standard Deviation 2.3 |
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time frame: Baseline (pre-operative)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 4.2 score on a scale | Standard Deviation 2.6 |
| Group 2 (30) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 4.0 score on a scale | Standard Deviation 1.7 |
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time frame: 2 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 5.0 score on a scale | Standard Deviation 2.1 |
| Group 2 (30) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 4.7 score on a scale | Standard Deviation 2.1 |
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time frame: 48 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 3.2 score on a scale | Standard Deviation 2.4 |
| Group 2 (30) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 3.3 score on a scale | Standard Deviation 2.1 |
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time frame: 7 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.3 score on a scale | Standard Deviation 2.4 |
| Group 2 (30) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.2 score on a scale | Standard Deviation 1.6 |
Numeric Pain Rating Scale (NPRS) Pain Scores
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Time frame: 21 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.6 score on a scale | Standard Deviation 2.3 |
| Group 2 (30) - Hip Arthroscopy | Numeric Pain Rating Scale (NPRS) Pain Scores | 2.0 score on a scale | Standard Deviation 1.8 |
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time frame: 7 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Remaining | 49.6 tablets | Standard Deviation 15.9 |
| Group 2 (30) - Hip Arthroscopy | Opiates Remaining | 22.3 tablets | Standard Deviation 8.4 |
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time frame: 48 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Remaining | 54.8 tablets | Standard Deviation 5.7 |
| Group 2 (30) - Hip Arthroscopy | Opiates Remaining | 25.1 tablets | Standard Deviation 5.9 |
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time frame: 21 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Remaining | 49.5 tablets | Standard Deviation 16.5 |
| Group 2 (30) - Hip Arthroscopy | Opiates Remaining | 22.0 tablets | Standard Deviation 7.9 |
Opiates Remaining
Number of prescribed narcotic medication tablets remaining from initial amount prescribed
Time frame: 24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Remaining | 57.0 tablets | Standard Deviation 2.2 |
| Group 2 (30) - Hip Arthroscopy | Opiates Remaining | 27.6 tablets | Standard Deviation 2.5 |
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Time frame: 7 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Taken | 10.4 tablets | Standard Deviation 15.9 |
| Group 2 (30) - Hip Arthroscopy | Opiates Taken | 8.8 tablets | Standard Deviation 9.3 |
Opiates Taken
Number of prescribed narcotic pills taken in the preceding time period
Time frame: 24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Taken | 3.0 tablets | Standard Deviation 2.2 |
| Group 2 (30) - Hip Arthroscopy | Opiates Taken | 2.4 tablets | Standard Deviation 2.5 |
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Time frame: 48 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Taken | 5.2 tablets | Standard Deviation 5.7 |
| Group 2 (30) - Hip Arthroscopy | Opiates Taken | 4.9 tablets | Standard Deviation 5.9 |
Opiates Taken
Number of prescribed narcotic medication tablets taken in the preceding time period
Time frame: 21 days post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (60) - Hip Arthroscopy | Opiates Taken | 10.5 tablets | Standard Deviation 16.5 |
| Group 2 (30) - Hip Arthroscopy | Opiates Taken | 9.2 tablets | Standard Deviation 11.1 |