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Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

NCT03380533 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-08

No results posted yet for this study

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

Interventions

DRUG

Buprenorphine

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

DRUG

Placebo Patch

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

DRUG

Multimodal Oral Scheme

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

DRUG

Tramadol

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

DRUG

Placebo Tablet

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

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-22
Primary Completion
2017-12-08
Completion
2021-04-06

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380533 on ClinicalTrials.gov