Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 22, 2016

Primary Completion Date

December 8, 2017

Study Completion Date

April 6, 2021

Conditions
Rotator Cuff TearRotator Cuff InjuryAnalgesics, OpioidBuprenorphine
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

Trial Locations (1)

1181

Hospital Italiano de Buenos Aires, Buenos Aires

All Listed Sponsors
lead

Hospital Italiano de Buenos Aires

OTHER

NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair | Biotech Hunter | Biotech Hunter