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临床试验/CTRI/2024/11/076389
CTRI/2024/11/076389已完成4 期

Comparison Of Intrathecal Hyperbaric Bupivacaine with Fentanyl Versus Hyperbaric Ropivacaine with fentanyl for perineal surgeries under Subarachnoid block : A Randomised controlled study

Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年11月26日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Time for sensory blockade at T10

研究概览

简要总结

Subarachnoid block is commonly practiced worldwide as a standard of care for perineal, lower abdominal and lower limb surgeries. It has been proven that combination of adjuvants to local anaesthetic prolong duration of analgesia postoperatively.Ropivacaine has high pka, low lipid solubility[3].It is found to block sensory nerves to a greater degree than motor nerves .Ropivacaine and Bupivacaine have similar local anesthetic properties and chemical structure[1][4]. Ropivacaine is expected to be a suitable drug for day care surgeries because of less motor block with great sensory motor dissociation and could be associated with early post-operative mobilization.

The concept of day-care or ambulatory surgery has been well established in developed countries though it is still in its infancy in developing countries such as India. There is an immense opportunity for expansion in day-care surgery in India with it’s huge population of 1.2 billion and expanding private sector .

In India, there is lack of studies with proper documentation regarding day-care anaesthesia . 11%–23% of the surgeries in India performed in hospital settings are considered to be on outpatient basis based on available data from unpublished source.

The study aims to compare relatively novel drug ropivacaine with bupivacaine in it’s effectiveness in terms of duration of anaesthesia , intraoperative quality of block and post operative recovery in perineal surgeries , a ususal form of ambulatory surgery. The identification of a suitable drug for ambulatory surgeries would help in popularizing the method of surgery and would cut down cost ,easy return to work , lack of dependency on availability of hospital beds, reduced nosocomial infection rates for patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • American Societ of Anaesthesiologists (ASA) Grade 1 and 2 patients undergoing perineal surgeries under subarachnoid block.

排除标准

  • Patients refusing to participate in study Patients with history of hypersensitivity to local anesthetics Emergency cases and cases with ASA Grade 3 or above Patients with sepsis in Lumbar region,Patients with pre-existing neurological disorders or spine deformity Surgeries involving major blood loss.

结局指标

主要结局

Time for sensory blockade at T10

时间窗: Every one minute | Every one minute

Time for highest sensory blockade

时间窗: Every one minute | Every one minute

Time for complete Motor blockade

时间窗: Every one minute | Every one minute

Hemodynamic parameters

时间窗: Every one minute | Every one minute

次要结局

  • Time for complete Motor regression(Time for complete sensory regression)

研究者

发起方
Bangalore Medical College and Research Institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DrGayathri K V

Bangalore Medical College and Research Institute

研究点 (1)

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