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OpenTrials
Completed

NCT Number: NCT03380533

Buprenorphine Transdermal Patches 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., 1181, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

buprenorphine

Drug

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

Other names: Buprenorphine Patch

Placebo Patch

Drug

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

Multimodal Oral Scheme

Drug

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

Tramadol

Drug

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

Other names: Tramadol Tablet

Placebo Tablet

Drug

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

Primary outcomes

  1. Pain perception

    Time frame: Five days

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

Secondary outcomes

  1. Consumption of rescue opiods

    Time frame: Five Days

    consumption of rescue opiods

  2. Hours of sleep

    Time frame: 5 days

    hours of sleep

  3. Perception of Sickness

    Time frame: 5 days

    presence or not of nausea

  4. Readmissions rate

    Time frame: 5 days

    record of hospital readmissions for pain or complications related to the use of buprenorphine patches

  5. Misuse or abuse of opioids rate

    Time frame: Fourth month post operatory

    Behaviors of misuse or abuse of opioids after the immediate postoperative period

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Dec 21, 2017
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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