Phase 2 N=70 Randomized Single-blind Treatment

Nonopioid Analgesia After Rotator Cuff Repair

Rotator Cuff Tear

Bottom Line

View on ClinicalTrials.gov: NCT03818919 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Pain Levels — 2.4; 3 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Celecoxib (Drug); Ketorolac (Drug); Gabapentin (Drug); Acetaminophen (Drug); Diazepam (Drug); Hydrocodone-Acetaminophen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Henry Ford Health System
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Levels	2.4; 3	—
PRIMARY Patient-Reported Outcomes Measurement Information System	59.3; 60.0	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03818919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.