Recruiting

Pain Control Medications

Sponsor:

Montefiore Medical Center

Code:

NCT07076069

Conditions

Rotator Cuff Repairs

Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multimodal Pain Regimen

Standard of Care Pain Regimen

Study Details

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.

Conditions

Rotator Cuff Repairs

Pain Management

Study ID

NCT07076069

Start date

Jul 21, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Standard Pain Regimen Group

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

experimental: Multimodal Pain Regimen Group

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.

Interventions

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

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

Primary outcome measure

  • Post-operative narcotics usage [ Time Frame: Post-operative day 7 ]
  • Pain Score using the Visual Analogue Scale (VAS) [ Time Frame: Post-operative day 7 ]

Central Contacts and Locations

Central contacts

Ferdinand Chan, M.D.

718-920-2060fchan@montefiore.org

Locations

Montefiore Hutchinson Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Ferdinand Chan, M.D.

718-920-2060fchan@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-13.