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临床试验/CTRI/2025/01/078977
CTRI/2025/01/078977尚未招募4 期

Effect of Continuous Rectus Sheath Block Compared To Epidural Analgesia on Post-Operative Hemodynamic Stability in Patients Undergoing Elective Midline Laparotomy-A Randomised Controlled Trial

SRM Medical College and Reasearch Center1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月14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
64
试验地点
1
主要终点
to study the effect of rectus sheath block compared to epidural analgesia on post operative hemodynamic stability in patients undergoing elective mid-line laparotomy

研究概览

简要总结

A total of 64 patients that are over the age of 18, consenting and undergoing elective surgery under ASA PS 1-3 will be enrolled in this RCT. Patients will be divided into two groups-control and trial. The control group will receive an epidural catheter placed pre-operatively and activated post operatively. They will receive a patient controlled analgesia pump that provides a continuous infusion, two ml boluses at a lock out period of up to twenty minutes. the trial group will receive a bilateral rectus sheath block postoperatively and a patient controlled analgesia pump will deliver five ml per hour per side of the same ropivacaine solution. the bolus and lockout period will be set the same as the control group. post operatively data will be collected by observation of the vital parameters at regular time intervals for forty eight hours.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • elective surgery hemodynamically stable.

排除标准

  • patients with spine abnormalities difficult airway patient on ventilators pregnant women contraindications to ropivacaine or epidural analgesia ASA PS III including implanted pacemaker, ESRD on dialysis not consenting known bleeding diasthesis.

结局指标

主要结局

to study the effect of rectus sheath block compared to epidural analgesia on post operative hemodynamic stability in patients undergoing elective mid-line laparotomy

时间窗: every 2 hours for the 48 hours post operatively

次要结局

  • pain relief(incidence of DVT)

研究者

发起方
SRM Medical College and Reasearch Center
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Lakshme Sanjana Karthik

SRM Medical College and Research Center

研究点 (1)

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