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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Spine Injuries and Disorders, Narcotic Use

Intervention / Treatment
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* Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing elective spine surgery<br> | Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 
| Opioid Sparing and Rescue Time | Time interval from patient extubation to time when pain medication is first demanded in the PACU | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in Hospital |  | Up to 12 days |