Phase 4
N=44
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Pain, Postoperative · Spine Injuries and Disorders · Narcotic Use
Bottom Line
View on ClinicalTrials.gov: NCT04522206 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Visual Analogue Scale (VAS) for Pain — 4.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) for Pain |
4.8 | — |
| PRIMARY Opioid Sparing and Rescue Time |
1.5 | — |
| SECONDARY Length of Stay in Hospital |
139 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04522206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.