Narcotic Use, Pain, Postoperative, Spine Injuries and Disorders
Conditions
Brief summary
The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.
Interventions
DRUGPre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of: Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A prospective cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing elective spine surgery at NYU Winthrop * Age over 18 years
Exclusion criteria
* History of neuromuscular disorders * History of inflammatory arthropathies * History of spine metastases or active cancer in spine * Medical History including any of the following: renal dysfunction, gastric ulcers, hepatic dysfunction, coagulopathic/bleeding disorders, prior adverse or allergic reactions to any of the medications in the study * Age less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for Pain | 24 hours | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. |
| Opioid Sparing and Rescue Time | 24 hours | Time interval from patient extubation to time when pain medication is first demanded in the PACU |
Secondary
| Measure | Time frame |
|---|---|
| Length of Stay in Hospital | Up to 12 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Undergoing Elective Spine Surgery Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone: The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of:
Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Patients Undergoing Elective Spine Surgery |
|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Opioid Sparing and Rescue Time
Time interval from patient extubation to time when pain medication is first demanded in the PACU
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Undergoing Elective Spine Surgery | Opioid Sparing and Rescue Time | 1.5 Hours | Standard Deviation 2.2 |
Primary
Visual Analogue Scale (VAS) for Pain
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Undergoing Elective Spine Surgery | Visual Analogue Scale (VAS) for Pain | 4.8 score on a scale | Standard Deviation 2.6 |
Secondary
Length of Stay in Hospital
Time frame: Up to 12 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patients Undergoing Elective Spine Surgery | Length of Stay in Hospital | 139 Hours |