Nonopioid Analgesia After Rotator Cuff Repair

Status Completed

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03818919
Study type	Interventional
Source	Henry Ford Health System
Contact
Status	Completed
Phase	Phase 2
Start date	January 22, 2019
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03663036` - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis	N/A
Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4
Suspended	`NCT03290196` - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics	Phase 4
Active, not recruiting	`NCT03091075` - Oxandrolone Rotator Cuff Trial	N/A
Completed	`NCT03380533` - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair	Phase 2/Phase 3
Completed	`NCT04566939` - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting	`NCT02716441` - Rotator Cuff Failure With Continuity
Completed	`NCT03540030` - Opioid-Free Shoulder Arthroplasty	Phase 4
Completed	`NCT02298023` - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)	Phase 2
Completed	`NCT02850211` - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair	Phase 4
Completed	`NCT01459536` - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear	N/A
Completed	`NCT01383239` - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs	N/A
Completed	`NCT01170312` - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation	N/A
Terminated	`NCT00936559` - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair	Phase 1
Completed	`NCT01204606` - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)	N/A
Completed	`NCT00852657` - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff	N/A
Active, not recruiting	`NCT00182299` - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS	Phase 4
Recruiting	`NCT06120998` - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed	`NCT05897866` - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)	N/A
Completed	`NCT02644564` - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.