NCT03825809

Nonopioid Analgesia After Labral Surgery

Traditional vs. Nonopioid Analgesia After Labral Surgery

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Detailed description

Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty. Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure. Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.

Conditions

• Narcotic Use

Interventions

Type	Name	Description
DRUG	Celecoxib	Post-Operative Non Opioid Pain Protocol
DRUG	Hydrocodone-Acetaminophen	Traditionally used narcotic pain protocol
DRUG	Ketorolac	Post-Operative Non Opioid Pain Protocol
DRUG	Gabapentin	Post-Operative Non Opioid Pain Protocol
DRUG	Acetaminophen	Post-Operative Non Opioid Pain Protocol
DRUG	Diazepam	Post-Operative Non Opioid Pain Protocol

Timeline

• Start date: 2019-01-22
• Primary completion: 2020-01-20
• Completion: 2020-05-20
• First posted: 2019-01-31
• Last updated: 2019-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study