CTRI/2024/07/071076尚未招募不适用
A comparative of intrathecal isobaric ropivacaine 0.5 percent with fentanyl versus isobaric ropivacaine 0.5 percent in elective lower segment caesarean section surgeries.
Mahatma Gandhi Medical College and Hospita1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年8月5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
- 140
- 试验地点
- 1
- 主要终点
- A comparassion intrathecal isobaric ropivacaine 0.5% with fentanyl v/s isobaric ropivacaine 0.5% in elective lower segment caesarean section surgeries to study duration of analgesia,
研究概览
简要总结
- Subarachnoid block is the most widely used regional anaesthetic procedure for lower abdominal and lower limb surgery including lower segment caesarean section (LSCS). It provide rapid onset, consistent sensory and motor blockade with adequate muscle relaxation and for all types of surgery below the level of umbilicus. Regional anaesthesia is safer than general anaesthesia and having advantage of the parturient being awake during the birth process. Intrathecal local anaesthetics (LA) alone are not enough for effective postoperative analgesia and higher dose of LA are also associated with haemodynamic instability, which can lead to unfavourable maternal and foetal outcome. So far, many adjuvants have been used to augment the analgesia produced by intrathecal LA and to reduce their adverse effects. It has been well documented that the combination of fentanyl and LA administered intrathecally has synergistic analgesic effects. Fentanyl is a lipophilic j-receptor opioid agonist. Intrathecally, fentanyl exerts its effect by combining with opioid receptors in the dorsal horn of spinal cord and may have a supra spinal spread and action.Hyperbaric bupivacaine (0.5%), an amide-type of local anaesthetic, has been the gold standard for intrathecal use in spinal anaesthesia for many years but also has been associated with severe hypotension, delayed recovery of motor block, and cardiotoxicity when used in large concentration or when accidentally administered intravascularly. The introduction of ropivacaine has a better margin of safety for local anaesthetic systemic toxicity. Various studies have evaluated the effectiveness of these newer drugs for spinal anaesthesia using hyperbaric and isobaric solutions with a reliable rate of success. The study includes 140 pregnant patients aged, ASA grade I, and II scheduled for surgeries under subarachnoid block enrolled in this study and allocated into two groups of 70 patients each. After shifted to the operating room, standard ASA monitoring was attached. Group RF- received intrathecally 0.5% Isobaric Ropivacaine (2.0 ml) +25mcg(0.5ml) fentanyl Group R- received intrathecally 0.5% Isobaric Ropivacaine (2.0 ml)+ 0.5ml NS 0.9Parameters noted were Hemodynamic parameters were recorded,immediately after administration of intrathecal drugs, 1 min, 3 min, 5 min, 10 min, 15 min, 30 min, 60 min, 90 min and 120 min after administration of intrathecal drugpost-operatively 15 min, 1hr and 2 hr. Time of onset, time to achieve maximum level and duration of sensory block noted &Time of onset and duration of motor block notedPostoperative pain was assessed by the VAS scale and total analgesic requirement in the first 24 hours in two groups.Rescue Analgesia IV Diclofeneac 75mg IV SoS.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA physical status I-II 2) Pregnant females scheduled for elective lower segment C section surgeries.
排除标准
- •Patient with known psychiatric disorders, 2)Coagulopathy disorders 3)Infection at the site of block placement 4)Morbid obesity 5)Known Drug Allergie.
结局指标
主要结局
A comparassion intrathecal isobaric ropivacaine 0.5% with fentanyl v/s isobaric ropivacaine 0.5% in elective lower segment caesarean section surgeries to study duration of analgesia,
时间窗: at baseline ,at the time od induction of anaesthesia, after 1minutes of induction, 5minutes, 10minutes, 20 minutes, 30 minutes, 60minutes, 90 minutes, 120 minutes
次要结局
- Time of onset, time to achieve maximum level and duration of sensory block. Time of onset and duration of motor block.Postoperative pain assessment (VAS score) and total analgesic requirement in the first 24 hours in two groups.(To assess the side effects like nausea, vomiting, pruritis etc.)
研究者
Ayush Satishkumar Gupta
Mahatma Gandhi Medical College and Hospital, Jaipur
研究点 (1)
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