Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

NCT03380533 | Completed Phase 2 DMC

• 1 other identifier: 2960
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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) 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

Conditions

Rotator Cuff Tear; Rotator Cuff Injury; Analgesics, Opioid; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• Pain perception

  subjective perception of pain through the use of an analogous visual scale

  Five days

Secondary Outcomes (5)

• Consumption of rescue opiods

  Five Days

• Hours of sleep

  5 days

• Perception of Sickness

  5 days

• Readmissions rate

  5 days

• Misuse or abuse of opioids rate

  Fourth month post operatory

Study Arms (2)

Buprenorphine Patch

ACTIVE COMPARATOR

Buprenorphine 10mg Patch + Placebo Tablet + Multimodal Oral Scheme Multimodal Oral Scheme: Diclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)

Drug: Buprenorphine; Drug: Multimodal Oral Scheme; Drug: Placebo Tablet

Tramadol Tablet

ACTIVE COMPARATOR

Placebo Patch + Tramadol 50mg Tablet + Multimodal Oral Scheme Multimodal Oral Scheme: Diclofenac 75mg c 12h Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)

Drug: Placebo Patch; Drug: Multimodal Oral Scheme; Drug: Tramadol

Interventions

Buprenorphine DRUG

Buprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair

Also known as: Buprenorphine Patch

Buprenorphine Patch

Placebo Patch DRUG

Adhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs.

Tramadol Tablet

Multimodal Oral Scheme DRUG

Diclofenac 75mg c 12h Tramadol 50mg c 12h. Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)

Buprenorphine Patch; Tramadol Tablet

Tramadol DRUG

Tramadol 50mg tablet that the patient consumes every 8 hours during the first five days

Also known as: Tramadol Tablet

Tramadol Tablet

Placebo Tablet DRUG

Placebo tablet that the patient consumes every 8 hours during the first five days

Buprenorphine Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

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

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Buprenorphine; Tramadol

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 21, 2017
• Study Start: September 22, 2016
• Primary Completion: December 8, 2017
• Study Completion: April 6, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

AR (1)