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

Montefiore Medicine Academic Health System

Status and phase: Enrolling; Phase 4

Conditions: Pain Management; Rotator Cuff Repairs

Treatments: Drug: Multimodal Pain Regimen; Drug: Standard of Care Pain Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT07076069

2022-14249

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with rotator cuff tears who have failed conservative therapy and are now 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Standard Pain Regimen Group

Active Comparator group

Description:

Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.

Treatment:

Drug: Standard of Care Pain Regimen

Multimodal Pain Regimen Group

Experimental group

Description:

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.

Treatment:

Drug: Multimodal Pain Regimen