Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07076069

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Hutchinson Campus

The Bronx, New York, 10461, United States

Location status: Recruiting

Location contact

Ferdinand Chan, M.D.

CONTACT

[email protected]

718-920-2060

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal Pain Regimen

Drug

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

Drug

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 outcomes

  1. Post-operative narcotics usage

    Time frame: 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.

  2. Pain Score using the Visual Analogue Scale (VAS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ferdinand Chan, M.D.

CONTACT

[email protected]

718-920-2060

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 21, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.