Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

The Use of Buprenorphine Transdermal Patches Improves Post-Operative Pain Management in Arthroscopic Rotator Cuff Repair?

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear; Buprenorphine; Rotator Cuff Injury; Analgesics, Opioid
• Intervention / Treatment: Drug: Buprenorphine; Drug: Multimodal Oral Scheme; Drug: Placebo Tablet; Drug: Placebo Patch; Drug: Tramadol

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba
    • Buenos Aires, Caba, Argentina, 1181
      • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Buprenorphine Patch; 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; Buprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair; Other Names: Buprenorphine Patch; 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: Placebo Tablet; Placebo tablet that the patient consumes every 8 hours during the first five days
ACTIVE_COMPARATOR: Tramadol Tablet; 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: 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: Placebo Patch; Adhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs.; Drug: Tramadol; Tramadol 50mg tablet that the patient consumes every 8 hours during the first five days; Other Names: Tramadol Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	subjective perception of pain through the use of an analogous visual scale	Five days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Italiano de Buenos Aires

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 22, 2016
• Primary Completion (ACTUAL): December 8, 2017
• Study Completion (ACTUAL): April 6, 2021

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (ACTUAL): December 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Tramadol
• Other Study ID Numbers: 2960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No