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临床试验/CTRI/2024/07/070506
CTRI/2024/07/070506尚未招募4 期

Efficacy Of Bilateral Subcostal Plus Lateral Transversus Abdominis Plane Block For Post Operative Analgesia In Patients Undergoing Laparoscopic Cholecystectomy

Dr. Shubhika Singh1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年7月20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
58
试验地点
1
主要终点
To study the efficacy of bilateral subcostal plus lateral transversus abdominis plane using VAS

研究概览

简要总结

The  present study is prospective, Randomized and comparative study done after approval of Institutional Ethics Committee in patients satisfying all inclusion and exclusion criteria planned for laparoscopic cholecystectomy under general anaesthesia. Multi para monitors , 0.25% Bupivacaine,VAS Score, QoR-40 Score and normal saline  0.9 % will be used as study tools.

The study population will be divided into two groups of 29 each . The first group will be given bilateral subcostal plus TAP block using local anaestheic agent and the second group will be given bilateral subcostal plus lateral TAP block using normal saline instead of local anaesthetic agent . All the parameters like postoperative VAS Score, QoR-40 score,

intraoperative hemodynamic changes (HR, SBP, DBP,MAP) will be

recorded. Postoperative pain score monitoring will be done using the VAS score at

30 mins ,2,4,8,12 and 24 hours after surgery. And at 24 hours after the

surgery, VAS and quality of Recovery-40 score will be completed by the

patient.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Patient giving consent
  • All Patients aged 18yrs -60 yrs
  • Both genders
  • ASA I & II undergoing laparoscopic cholecystectomy.

排除标准

  • Refusal of informed consent
  • Allergic to local anesthetic agent
  • Skin conditions precluding the block
  • Preoperative chronic dependence upon opioid medication
  • BMI less than 25 kg/m2
  • History of cardiovascular diseases .

结局指标

主要结局

To study the efficacy of bilateral subcostal plus lateral transversus abdominis plane using VAS

时间窗: till 24 hours post operatively

and QoR-40 score in post operative period against the control group undergoing laparoscopic

时间窗: till 24 hours post operatively

cholecystectomy.

时间窗: till 24 hours post operatively

次要结局

  • ● Visual analogue scale(VAS) score and QOR-40 Score(● Duration of analgesia)

研究者

发起方
Dr. Shubhika Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shubhika Singh

Government Medical College, Haldwani

研究点 (1)

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