NCT07076069 · Montefiore Medical Center
The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
What this study is about
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
View original scientific description
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
Interventions
DRUG
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
DRUG
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 measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- The Bronx, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations