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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522206
• Other study ID #: 20-00734
• Status: Completed
• Phase: Phase 4
• Start date: August 20, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: July 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Opioid Sparing and Rescue Time	Time interval from patient extubation to time when pain medication is first demanded in the PACU	24 hours
Secondary	Length of Stay in Hospital		Up to 12 days