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Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear, Rotator Cuff Injury, Analgesics, Opioid

Status
Completed
Phase
Phase 2
Locations
Argentina
Study Type
Interventional
Intervention
Buprenorphine
Placebo Patch
Multimodal Oral Scheme
Tramadol
Placebo Tablet
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Buprenorphine Patch

Tramadol Tablet

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Consumption of rescue opiods
consumption of rescue opiods
Hours of sleep
hours of sleep
Perception of Sickness
presence or not of nausea
Readmissions rate
record of hospital readmissions for pain or complications related to the use of buprenorphine patches
Misuse or abuse of opioids rate
Behaviors of misuse or abuse of opioids after the immediate postoperative period

Full Information

First Posted
December 8, 2017
Last Updated
April 6, 2021
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT03380533
Brief Title
Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair
Official Title
The Use of Buprenorphine Transdermal Patches Improves Post-Operative Pain Management in Arthroscopic Rotator Cuff Repair?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 22, 2016 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Rotator Cuff Injury, Analgesics, Opioid, Buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine Patch
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Tramadol Tablet
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Buprenorphine Patch
Intervention Description
Buprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair
Intervention Type
Drug
Intervention Name(s)
Placebo Patch
Intervention Description
Adhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs.
Intervention Type
Drug
Intervention Name(s)
Multimodal Oral Scheme
Intervention Description
Diclofenac 75mg c 12h Tramadol 50mg c 12h. Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Tramadol Tablet
Intervention Description
Tramadol 50mg tablet that the patient consumes every 8 hours during the first five days
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
Placebo tablet that the patient consumes every 8 hours during the first five days
Primary Outcome Measure Information:
Title
Pain perception
Description
subjective perception of pain through the use of an analogous visual scale
Time Frame
Five days
Secondary Outcome Measure Information:
Title
Consumption of rescue opiods
Description
consumption of rescue opiods
Time Frame
Five Days
Title
Hours of sleep
Description
hours of sleep
Time Frame
5 days
Title
Perception of Sickness
Description
presence or not of nausea
Time Frame
5 days
Title
Readmissions rate
Description
record of hospital readmissions for pain or complications related to the use of buprenorphine patches
Time Frame
5 days
Title
Misuse or abuse of opioids rate
Description
Behaviors of misuse or abuse of opioids after the immediate postoperative period
Time Frame
Fourth month post operatory

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient diagnosed with rotator cuff injury, regardless of the type of injury. Patient undergoing Arthroscopic Rotator Cuff Repair Exclusion Criteria: 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.
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1181
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

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