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临床试验/CTRI/2025/03/083443
CTRI/2025/03/083443尚未招募4 期

Comparison of spread of local anaesthetic mixture and their analgesic efficacy between two point and four point rectus sheath block in cancer patients undergoing midline laparotomy surgeries

not applicable1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年4月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
66
试验地点
1
主要终点
to evaluate and compare the spread of LA in rectus sheath plane between two techniques

研究概览

简要总结

BACKGROUND: Rectus sheath block (RSB) provides excellent analgesia for midline abdominal procedures. The lacuna in the literature in comparing 2points with 4points RSB in conjunction with the spread of drugs and its analgesic efficacy during intraoperative and postoperative period is being addressed in this study.

AIM: To compare the efficacy of analgesia and drug spread between the two techniques of RSB in midline laparotomy surgeries.

METHODOLOGY: patients were divided into group-1(n=33) receiving 2-point RSB and group-2(n=33) receiving 4-point RSB using 0.25% ropivacaine with 4mg dexamethasone. People willing to give written informed consent, weighing >50kg and aged >18years assessed under ASA 1 to 4 are included in this study. Outcomes such as spread of local anaesthetics between 2 techniques after 10min of block procedure and their analgesic efficacy intraoperatively based on vitals recorded every 10min for first 1hour and thereafter every 30min once till the end of surgery, requirement of rescue analgesics (epidural bolus and opioids) and postoperatively based on VAS score recorded at 0,1,2, 4,6,8,12 hrs and rescue analgesics used were noted.

RATIONAL FOR THE STUDY:

Even though there are many literatures stating the efficacy of analgesia with rectus sheath block none of them explained the spread of local anaesthetics in posterior rectus sheath plane. There is a lacuna in the literature in comparing the spread of local anaesthetics between 2points and 4points RSB and its efficacy with respect to intraop and post op analgesia.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • patient willing to give informed consent, assessed under ASA 1-4, weight more than 50kg.

排除标准

  • patient with low IQ, allergic to LA, infection at the site of injection.

结局指标

主要结局

to evaluate and compare the spread of LA in rectus sheath plane between two techniques

时间窗: 10minutes after the block

次要结局

  • To evaluate & compare the efficacy of analgesia intraoperatively based on vitals & requirement of epidural & intravenous analgesics & postoperatively based on VAS score between two techniques

研究者

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

Dr.Sivabalakumaran

MVR Cancer Center and Research Institute

研究点 (1)

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