Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

Phase 2

Completed

• Conditions: Rotator Cuff Tear; Rotator Cuff Injury; Analgesics, Opioid; Buprenorphine
• Interventions: Drug: Placebo Patch; Drug: Buprenorphine; Drug: Multimodal Oral Scheme; Drug: Placebo Tablet; Drug: Tramadol

• Registration Number: NCT03380533
• Lead Sponsor: Hospital Italiano de Buenos Aires

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

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, frequently associated with side effects, such as nausea, vomiting, constipation, disorientation, among others, which, in the context of an outpatient, interfere with the postoperative period, sometimes resulting in hospital readmissions. due to both the poor management of pain and the adverse effects of opioids.

Although there are invasive strategies of analgesia, such as the placement of continuous infusion catheters of analgesics in the sub-acromial space, these are methods that demand the management of the devices, in some cases requiring prolongation of hospitalization for the patient. management of the same, without being exempt from complications as any analgesic method added to those related to the method.

Currently, the post-operative analgesia strategy widely accepted globally and that used in our center, is multimodal analgesia, in which NSAIDs (Anti-Inflammatory Non-Steroids) and oral opioids are associated. A combination of both analgesic mechanisms of action is used as a basic scheme, and rescues with opioids are carried out orally. Although the literature supports its cost-benefit, this approach is often insufficient, not achieving adequate control of postoperative pain in ARCR, with 64% of our patients reporting poor pain management in the first week of post-operative and 10% that require re-entry to day hospital for pain management.

The application of transdermal opioid release patches is a method of non-invasive analgesia, which has previously been used with good results for the management of postoperative pain. In ARCR there is no evidence of its use in the management of post-operative pain The main advantages could be related to the plasma stability of the drug (buprenorphine), which implies fewer peaks and valleys of analgesia, a better compliance by the patient since it is of weekly duration and lower incidence of cognitive deterioration related to other opioids.

Compared with other opioids, buprenorphine is associated with a lower risk of abuse, overdose and poisoning due to the ceiling effect. Despite this favorable pharmacological profile, the use of buprenorphine in patches has a lower abuse rate than other forms of administering the same drug. On the one hand, the release rate of the patch may be insufficient to satisfy the compulsive desire and, to that end, the patch may be less desirable. On the other hand, the availability in the market and the way to use the patches could be other conditioning factors.

Study Timeline

• Study Start: 2016-09-22
• Primary Completion: 2017-12-08
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-21
• Status Verified: 2021-04
• Study Completion: 2021-04-06
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine Patch	Multimodal Oral Scheme	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)
Buprenorphine Patch	Placebo Tablet	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)
Tramadol Tablet	Placebo Patch	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)
Tramadol Tablet	Multimodal Oral Scheme	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)
Buprenorphine Patch	Buprenorphine	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)
Tramadol Tablet	Tramadol	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)

Primary Outcome Measures

Name	Time	Method
Pain perception	Five days	subjective perception of pain through the use of an analogous visual scale

Secondary Outcome Measures

Name	Time	Method
Readmissions rate	5 days	record of hospital readmissions for pain or complications related to the use of buprenorphine patches
Hours of sleep	5 days	hours of sleep
Perception of Sickness	5 days	presence or not of nausea
Consumption of rescue opiods	Five Days	consumption of rescue opiods
Misuse or abuse of opioids rate	Fourth month post operatory	Behaviors of misuse or abuse of opioids after the immediate postoperative period

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Caba, Argentina