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临床试验/CTRI/2025/07/090252
CTRI/2025/07/090252尚未招募4 期

Comparison Between Ultrasound Guided Bilateral External Oblique Intercostal Plane Block And Pre-incisional Port Site Local Infiltration For Postoperative Analgesia in Undergoing Laparoscopic Cholecystectomy

Government Medical College Baroda1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年7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
124
试验地点
1
主要终点
Time to assess first rescue analgesia (Inj. Tramadol in 2mg/kg)

研究概览

简要总结

The Purpose of this study is to compare post-operative analgesia after Bilateral External Oblique Intercostal Plane Block and Pre-incisional port site local infiltration, postoperative total requirenment of analgesic drugs, assess hemodynamic parameter, early recovery in adult patients undergoing laparoscopic cholecystectomy.

The patients will be randomly allocated into two groups by using computerised randomisation in a 1:1 ratio to undergo bilateral ultrasound guided external oblique intercostal plain block and pre-incisional port-site instillation of local anaesthetics.

In group B, patient will be given bilateral ultrasound guided external oblique intercostal plane block after giving general anaesthesia.

 In group L, patient will be given pre-incisional port-site local infiltration after giving general anaesthesia.

This study may superior in post operative analgesia with higher safety margin in patients laparoscopic cholecystectomy with ultrasound guided bilateral external oblique intercostal plane block as a part of multimodal 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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18-65 years ASA Grade One And TWO patient schedule for elective laparoscopic cholecystectomy patient able to give verbal and informed consent patient able to understand VAS regarding assessment of pain.

排除标准

  • Refusal of patient History of allergy to local anaesthetic drug Skin infection at puncture site Coagulation disorders Cardio pulmonary/hepatorenal disease Pregnancy.

结局指标

主要结局

Time to assess first rescue analgesia (Inj. Tramadol in 2mg/kg)

时间窗: Till 24 hours

Time interval from block performance to requirement of first rescue analgesia.

时间窗: Till 24 hours

次要结局

  • To evaluate post operative analgesia using visual analogue scale (VAS) measured at 0,1,2,4,6,8,12,18,24 hours at rest and on movement(Intra-operative dexmedetomidine requirement)

研究者

发起方
Government Medical College Baroda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Gandev J Chaudhari

Government Medical College Baroda

研究点 (1)

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