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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Before surgeries, patients will be assigned to one of the two arms in a block randomization fashion in a 1:1 ratio. A block randomization scheme with a block size of 6 will be generated and maintained by the study statistician.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard Pain Regimen Group 		Patients will be prescribed the current department-wide postoperative pain protocol as described in the Intervention Description.
  • 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
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.
  • 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

Recruiting Locations

Montefiore Hutchinson Campus
The Bronx, New York 10461
Contact:
Ferdinand Chan, M.D.
718-920-2060
fchan@montefiore.org

More Details

Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Ferdinand Chan, M.D.
718-920-2060
fchan@montefiore.org

Detailed Description

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.