CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodonedrug
Likely dose
Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone 975 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04522206
NCT04522206Phase 4Completed

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

NYU Langone Health·interventional·Posted Aug 21, 2020·Updated Jul 11, 2022

In Brief

A Phase 4 clinical trial evaluating Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone for Pain, Postoperative and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 21, 2020
Enrollment StartAug 20, 2020
Primary CompletionJun 10, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.9 years ago

Interventions

Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodonedrug

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