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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Repairs; Pain Management
• Interventions: Drug: Standard of Care Pain Regimen; Drug: Multimodal Pain Regimen

• Registration Number: NCT07076069
• Lead Sponsor: Montefiore Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-13
• Study Start: 2025-07-21
• Study First Posted: 2025-07-21
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-13
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Adults with rotator cuff tears who have failed conservative therapy and undergoing arthroscopic rotator cuff repair.

Exclusion Criteria

• Patients without capacity to consent for the study
• Patients not able to have local nerve block
• Patients who underwent previous shoulder surgery on the same side, kindling revision rotator cuff repair
• Patients who are unable to record and verbalize their pain level due to altered mental status
• Patients who are unable to tolerate any of the medications included in the multimodal pain regimen or standard pain regimen due to severe allergies or inability to consume medication
• Patients with history of previously diagnosed alcohol or drug abuse, renal impairment, peptic ulcer disease, and gastrointestinal bleeding
• Patients who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Pain Regimen Group	Standard of Care Pain Regimen	Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.
Multimodal Pain Regimen Group	Multimodal Pain Regimen	Multimodal pain regimen medications will be prescribed and administered preoperatively in preoperative holding area, intraoperatively during the procedure, and postoperatively as described in the Intervention Description.

Primary Outcome Measures

Name	Time	Method
Post-operative narcotics usage	Post-operative day 7	Post-operative narcotics usage will be assessed by the number of oxycodone tablets used in the first week (7 days) after surgery. The week's use will be accounted by counting the left-over oxycodone tablets brought in by the patients. In addition, the electronic medical record will be checked to ensure that no extra narcotics were called in. Results will be summarized by study arm using means and standard deviations.
Pain Score using the Visual Analogue Scale (VAS)	Post-operative day 7	A pain score will be determined using the VAS, a unidimensional measure of pain intensity. Patients will be asked to rate and record pain intensity daily during the study. The VAS score at post-operative day 7 will be reported. The VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100, such that higher scores are indicative of greater pain intensity. Results will be summarized by study arm using basic descriptive statistics.

Trial Locations

Locations (1)

Montefiore Hutchinson Campus; 🇺🇸 Bronx, New York, United States