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

NCT04522206 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-00734
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Spine Injuries and Disorders; Narcotic Use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Length of Stay in Hospital

  Up to 12 days

Study Arms (1)

Patients undergoing elective spine surgery

EXPERIMENTAL

Drug: Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone

Interventions

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

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

Patients undergoing elective spine surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Disease

Interventions

Methylmalonic Acid; Clinical Protocols

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Malonates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Muhammad B. Tariq, M.D
• Organization: NYU LAngone Health - Long Island

Muhammad.Tariq2@nyulangone.org

602-363-1134

Study Officials

• Muhammad Tariq, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective cohort study

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 21, 2020
• Study Start: August 20, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: July 11, 2022
• Results First Posted: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Requests may be directed to the PI.

Locations

US (1)