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临床试验/CTRI/2022/08/044612
CTRI/2022/08/044612尚未招募不适用

Comparative study of Tramadol and Buprenorphine Transdermal patch for postoperative analgesia in Nephrectomy surgery.

Mahatma Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients.

研究概览

简要总结

Postoperative pain is a majorconcern for patients undergoing Nephrectomy surgery. Pain can be associatedwith adverse physiological and psychological effects hampering the normalrecovery process. Preventive analgesia, initiated beforethe surgical procedure, can theoretically reduce pain sensitization, butmultiple clinical studies have failed to demonstrate convincing clinicalbenefit.

Buprenorphine, a derivative ofthe opium alkaloid thebaine, is a more potent and longer lasting analgesic. Itsdissociation from opioid receptor binding is slow which probably accounts forits longer duration of action. The lack of delta receptor agonist activity maybe responsible for the observation that buprenorphine is less likely to inducetolerance on chronic use.

Buprenorphine is usedclinically for the treatment of moderate-to-severe pain, includingperioperative analgesia. A transdermal patch formulation of buprenorphinehas recently been introduced in the Indian market. Although expensive, thismode of delivery has several potential benefits over oral and parenteraladministration. These include noninvasive dosing, betterabsorption, lack of first-pass metabolism, and steady plasma concentration. Thebuprenorphine patch releases the analgesic steadily over 7 days and has beensuccessfully used to treat a variety of chronic pain conditions. However,there is limited clinical experience of its utility in postoperative pain.

  Tramadol is a centrally acting analgesic with weak opioidagonist. Its safety is well established by the fact that the clinicallyrelevant respiratory depression is not seen with tramadol and it has lowdependence and abuse potential. All these properties make tramadol as the idealdrug for the management of post-operative pain. Hence, tramadol is one of themost commonly used analgesics in post-operative period. Tramadol has goodbioavailability (70%–90%); hence, it has been used for providing post-operativeanalgesia. It should be used cautiously in patients with renal failure due torisk of accumulation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I/II Patient UnderGoing Nephrectomy Surgery Patient Written And Informed Consent.

排除标准

  • Allergy to Study Drug ASA Grade III/IV.

结局指标

主要结局

To compare Analgesic effect postoperatively between Tramadol and Transdermal Buprenorphine patch in Nephrectomy patients.

时间窗: 5-7 days

次要结局

未报告次要终点

研究者

发起方
Mahatma Gandhi Medical College
申办方类型
Private medical college

研究点 (1)

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