Status:

COMPLETED

Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

Lead Sponsor:

Hospital Italiano de Buenos Aires

Conditions:

Rotator Cuff Tear

Rotator Cuff Injury

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

Arthroscopic rotator cuff repair is associated with poor post-operative pain management. The multimodal analgesic scheme (oral non-steroidal anti-inflammatory drugs associated with oral opioids) curre...

Detailed Description

Traditionally, oral opioids have been used to manage the postoperative pain of arthroscopic rotator cuff repair (ARCR) . Due to the intensity of pain, it often requires high doses of opioids, frequent...

Eligibility Criteria

Inclusion

  • Patient diagnosed with rotator cuff injury, regardless of the type of injury.
  • Patient undergoing Arthroscopic Rotator Cuff Repair

Exclusion

  • Refusal to participate or inability to understand the informed consent process.
  • Inability to understand subjective scales of pain
  • Regular use of narcotics
  • Allergy or intolerance to drugs used in the protocol
  • Consumption of drugs that interact with Buprenorphine (anticholinergics, Atropine, Belladonna, Benztropine, Dicyclomine, Diphenhydramine, Isopropamide, Procyclidine and Scopolamine, Antiarrhythmics, Amiodarone, Disopyramide, Dofetilide, Procainamide, Quinidine and Sotalol.
  • Anticonvulsants; Carbamazepine, Phenobarbital, Phenytoin and Rifampin)
  • History of previous surgeries in shoulder treated with RAMR
  • Previous neuromuscular deficit
  • Febrile Syndrome
  • Autoimmune or Rheumatologic Disease
  • History of intestinal transit disorders (paralytic ileus)
  • History of alcohol or drug abuse
  • Patients in psychological or psychiatric treatment for anxiety disorders, personality disorders, mood disorders.

Key Trial Info

Start Date :

September 22 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 6 2021

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03380533

Start Date

September 22 2016

End Date

April 6 2021

Last Update

April 8 2021

Active Locations (1)

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1

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina, 1181