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Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03380533
Enrollment
50
Registered
2017-12-21
Start date
2016-09-22
Completion date
2021-04-06
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesics, Opioid, Buprenorphine, Rotator Cuff Injury, Rotator Cuff Tear

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.

Interventions

DRUGBuprenorphine

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

DRUGPlacebo Patch

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

DRUGMultimodal Oral Scheme

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

DRUGTramadol

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

DRUGPlacebo Tablet

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

Sponsors

Hospital Italiano de Buenos Aires
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain perceptionFive dayssubjective perception of pain through the use of an analogous visual scale

Secondary

MeasureTime frameDescription
Consumption of rescue opiodsFive Daysconsumption of rescue opiods
Hours of sleep5 dayshours of sleep
Perception of Sickness5 dayspresence or not of nausea
Readmissions rate5 daysrecord of hospital readmissions for pain or complications related to the use of buprenorphine patches
Misuse or abuse of opioids rateFourth month post operatoryBehaviors of misuse or abuse of opioids after the immediate postoperative period

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026