NCT07076069

The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.

Detailed description

The purpose of this study is to investigate whether a previously described multimodal pain protocol involving non-narcotic medications compared to the medical center's current postoperative pain regimen mainly involving narcotics will decrease total rescue narcotics used for patients who undergo arthroscopic rotator cuff tear repair at Montefiore. The implications of the study would be reduced narcotics consumptions in postoperative patients and improved self-reported patient outcomes. Through this study, the investigator team hopes to develop a pain regimen that alleviates dependence on opioids in postoperative patients without sacrificing patient satisfaction and comfort.

Conditions

• Rotator Cuff Repairs
• Pain Management

Interventions

Type	Name	Description
DRUG	Multimodal Pain Regimen	Preoperatively: One dose of Pregabalin 100mg and Celecoxib 400mg along with interscalene block Intraoperatively: Intravenous Dexamethasone 0.1mg/kg (maximum dose of 8mg), Magnesium 2g, Acetaminophen 1000mg, and local infiltration of 0.5% Ropivacaine 20ml Postoperatively (Discharge): Acetaminophen 975mg every 4 hours, Meloxicam 7.5mg once per day, Pregabalin 50mg twice per day, Magnesium 400mg once per day, along with rescue Oxycodone 5mg every 4 hours, as needed
DRUG	Standard of Care Pain Regimen	No preoperative medications. Interscalene block in the preoperative holding area. Alternating Acetaminophen 975mg and Ibuprofen 600mg every 4 hours, with rescue Oxycodone 5mg every 4 hours, as needed

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-07-21
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study