The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
Part of paid clinical trials in The Bronx, New York.
- Sponsor
- Montefiore Medical Center
- Study ID
- NCT07076069
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Pain Management
- Rotator Cuff Repairs
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Multimodal Pain Regimen — DRUGPreoperatively: 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
- Standard of Care Pain Regimen — DRUGNo 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
Study Details
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
Key Dates
- Start date
- Jul 21, 2025
- Status verified
- Jan 2026
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 130 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Standard Pain Regimen GroupPatients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.
- Experimental: Multimodal Pain Regimen GroupMultimodal 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 Measure
Post-operative narcotics usage [ Time Frame: Post-operative day 7 ]
Central Contacts
- Ferdinand Chan, M.D.718-920-2060
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Montefiore Hutchinson Campus | The Bronx | New York | 10461 |
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