Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

• Status: Completed
• Trial end date: 2021-04-06
• Target enrollment: 0
• Participant gender: All

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) currently used according to the pain management guidelines is insufficient for most of these patients.

There are few reports on the use of buprenorphine in post-operative pain with encouraging results. There is no evidence of its use in the management of post-operative pain of arthroscopic rotator cuff repair

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Italiano de Buenos Aires
• Treatments: Buprenorphine; Tramadol

Criteria

Inclusion Criteria:

• Patient diagnosed with rotator cuff injury, regardless of the type of injury.

• Patient undergoing Arthroscopic Rotator Cuff Repair

Exclusion Criteria:

1. Refusal to participate or inability to understand the informed consent process.

2. Inability to understand subjective scales of pain

3. Regular use of narcotics

4. Allergy or intolerance to drugs used in the protocol

5. 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)

6. History of previous surgeries in shoulder treated with RAMR

7. Previous neuromuscular deficit

8. Febrile Syndrome

9. Autoimmune or Rheumatologic Disease

10. History of intestinal transit disorders (paralytic ileus)

11. History of alcohol or drug abuse

12. Patients in psychological or psychiatric treatment for anxiety disorders, personality disorders, mood disorders.