Nonopioid Analgesia After Labral Surgery

Narcotic Use Clinical Trial

Official title:

Traditional vs. Nonopioid Analgesia After Labral Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825809
• Other study ID #: 1231914
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 22, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: January 2019
• Source: Henry Ford Health System
• Contact: Toufic R Jildeh, MD
• Phone: 517-230-8511
• Email: tjildeh1[@]hfhs.org
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility Criteria:

Inclusion Criteria:

• All adult patients over age 18 and scheduled for a primary or revision labral surgery

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

• Narcotic Use

Intervention

Drug:
• Celecoxib
Post-Operative Non Opioid Pain Protocol
• Hydrocodone-Acetaminophen
Traditionally used narcotic 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

Locations

Country	Name	City	State
United States	Henry 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 recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.	10 days post-operatively
Primary	Patient-Reported Outcomes Measurement Information System	Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.	10 days post-operatively