The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with rotator cuff tears who have failed conservative therapy and are now undergoing arthroscopic rotator cuff repair.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
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
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Standard Pain Regimen GroupActive comparator 1 intervention
Group B: Multimodal Pain Regimen GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative narcotics usage
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.
Time frame
Post-operative day 72
Pain Score using the Visual Analogue Scale (VAS)
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.
Time frame
Post-operative day 7Sponsors and contacts
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Source ClinicalTrials.gov