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临床试验/NCT03380533
NCT03380533已完成2 期

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

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年9月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Pain perception

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient diagnosed with rotator cuff injury, regardless of the type of injury.
  • Patient undergoing Arthroscopic Rotator Cuff Repair

排除标准

  • 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.

研究组 & 干预措施

Buprenorphine Patch

Active Comparator

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)

干预措施: Buprenorphine (Drug)

Buprenorphine Patch

Active Comparator

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)

干预措施: Multimodal Oral Scheme (Drug)

Buprenorphine Patch

Active Comparator

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)

干预措施: Placebo Tablet (Drug)

Tramadol Tablet

Active Comparator

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)

干预措施: Placebo Patch (Drug)

Tramadol Tablet

Active Comparator

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)

干预措施: Multimodal Oral Scheme (Drug)

Tramadol Tablet

Active Comparator

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)

干预措施: Tramadol (Drug)

结局指标

主要结局

Pain perception

时间窗: Five days

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

次要结局

  • Consumption of rescue opiods(Five Days)
  • Hours of sleep(5 days)
  • Perception of Sickness(5 days)
  • Readmissions rate(5 days)
  • Misuse or abuse of opioids rate(Fourth month post operatory)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BERNARDO AGUSTIN BERTONA ALTIERI

MD

Hospital Italiano de Buenos Aires

研究点 (1)

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