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

Phase 4

Completed

• Conditions: Pain, Postoperative; Spine Injuries and Disorders; Narcotic Use
• Interventions: Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone

• Registration Number: NCT04522206
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-19
• Study Start: 2020-08-20
• Study First Posted: 2020-08-21
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Results First Submitted: 2022-06-14
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-05
• Results First Posted: 2022-07-11
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Undergoing elective spine surgery at NYU Winthrop
• Age over 18 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing elective spine surgery	Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of Stay in Hospital	Up to 12 days

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States