Nonopioid Analgesia After Rotator Cuff Repair

Rotator Cuff Tear Clinical Trial

Official title:

Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818919
• Other study ID #: 123191
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 visual analogue scale and Patient-Reported Outcomes Measurement Information System. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair

Exclusion Criteria:

• Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Celecoxib
Post-Operative Non Opioid Pain Protocol
• Ketorolac
Post-Operative Non Opioid Pain Protocol
• Gabapentin
Post-Operative Non Opioid Pain Protocol
• Acetaminophen
Post-Operative Non Opioid Pain Protocol
• Diazepam
Post-Operative Non Opioid Pain Protocol
• Hydrocodone-Acetaminophen
Traditionally used narcotic pain protocol

Locations

Country	Name	City	State
United States	Health Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Levels	Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.	day 10 post-operative
Primary	Patient-Reported Outcomes Measurement Information System	Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference.	day 10 post-operative