跳至主要内容
临床试验/CTRI/2024/03/063850
CTRI/2024/03/063850尚未招募4 期

A Comparative study to assess the efficacy of 0.25%Ropivacaine and 0.25%Ropivacaine with Dexmeditomedine in Ultrasound guided Transverse Abdominis Plane Block for Postoperative analgesia in unilateral open inguinal hernia surgeries under General Anaesthesia.

Bangalore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To assess postoperative analgesia using VAS score

研究概览

简要总结

Hernia of abdominal wall are quite common having a prevalence of 1.7%for all ages and 4% for those older than 45years. Inguinal hernia repair (IHR) is one of the most common surgery, it is associated with 60% incidence of moderate to severe postoperative pain. Inguinal hernia repair is a relatively short and simple procedure. However, patients may experience moderate-to-severe post-operative pain that can affect their functional status and overall quality of life, which is of considerable concern who are at high risk for chronic pain, post-operative delirium (POD) and other post-operative complications. Ultrasonography-guided Transverse Abdominis Block is an effective peripheral abdominal field block ,which involves injecting local anesthetics into plane between internal oblique and transversus abdominis muscle ,where the intercostal ,subcostal,iliohypogastric ,ilioinguinal and genitofemoral nerve ,primarily innervate the lower abdominal wall. .TAP block provides significant analgesic effect especially below T10 upto L1 level,hence it is used in lower abdominal and gynecological surgeries. Ropivacaine is most commonly used local anesthetic for peripheral nerve block due to its prolonged duration of action,differential blockade and lesser cardiac toxicity.6 Dexmedetomidine is a selective alpha-2 adrenergic agonist with both analgesic and sedative properties. When administered as a perineural adjuvant, dexmedetomidine reduces initial blocking time while prolonging sensory and motor blockade duration.In this study we are comparing between 0.25%Ropivacaine and 0.25%Ropivacaine with Dexmedetomidine in Transverse Abdominis Plane block for unilateral inguinal hernia surgeries, in terms of efficacy and duration of analgesia.

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
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • American society of Anaesthesiologists (ASA1 and ASA2) Patients being operated for elective unilateral inguinal hernia under general anaesthesia.

排除标准

  • Patients not willing to give informed consent Patients with known allergy to any of study drug Recurrent inguinal hernia patients Emergency surgery.

结局指标

主要结局

To assess postoperative analgesia using VAS score

时间窗: To assess the VAS score at 1,3,6,12,24 hours post operatively.

次要结局

  • Time of first dose of rescue analgesia(Time of requirement of first dose of Tramadol 2mg per kg body weight)
  • Total opiod requirement(Tramadol).(Total opioid requirement(Tramadol) in 24 hours.)
  • Degree of sedation.(Degree of sedation using Modified Wilsons score at 1,3,6,12,18,24 hours postoperatively.)
  • To assess Hemodynamic parameters Heart rate and Mean Arterial Pressure post operatively.(To assess the Hemodynamic parameters Heart rate and Mean Arterial pressure at 1,3,6,12,18 hours post operatively)

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

Dr Likhitha H

Bangalore Medical College and Research Institute

研究点 (1)

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