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临床试验/CTRI/2024/08/073157
CTRI/2024/08/073157尚未招募4 期

comparison of modified thoracoabdominal plane nerve block through perichondrial approach and subcostal transversus abdomens plane block for quality of post operative analgesia in patients undergoing laparoscopic cholecystectomy a randomised controlled trial

Lady hardinge medical college and associated hospitals1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Median numeric pain rating score NRS in first 24 hours post operatively between thoracoabdominal nerve block and subcostal transversus abdominis block groups .

研究概览

简要总结

Now a days laparoscopic cholecystectomy is a procedure of choice in surgical treatment for

symptomatic cholelithiasis Recovery after laparoscopic cholecystectomy depends upon

several factors Such as abdominal pain nausea vomiting and fatigue Although post

operative pain after laparoscopic cholecystectomy mainly depends upon factors like

peritoneal stretching and diaphragmatic irritation caused by high intraabdominal pressure and

by carbon dioxide retention Nonetheless total abdominal pain following laparoscopic

cholecystectomy is having somatic and visceral components Therefore our aim should be

to reduce the somatic component of pain that is incisional pain after laparoscopic

cholecystectomy It has also been stated that laparoscopic cholecystectomy causes significant

postoperative pain in one third of post operative patients up to first 24 hours after surgery A

recent PROSPECT review reported that standard way to reduce postoperative pain after

laparoscopic cholecystectomy is preoperative or intraoperative use of paracetamol with

NSAID and port site Local anaesthetic infiltration with long acting local anaesthetic agent

and also suggests that there is no role of number of surgical port insertion recently

published review and meta-analysis suggest that subcostal transversus abdominis plane

TAP block is having greatest reduction in pain score at 12 hours postoperatively compared

with other regional analgesic techniques

Subcostal TAP block was first suggested by Hebbard et al. and it is proven to provide

adequate analgesia for upper and lower abdominal surgeries  However, pain from the

incision site for the right lateral port in the laparoscopic cholecystectomy may not be

covered because it cannot block the lateral cutaneous branches of the thoracoabdominal

nerves To compensate this shortcomings of subcostal TAP block, Tulgar et al. introduced a

newer regional analgesic technique called as modified thoracoabdominal nerve block

through the perichondral approach  M TAPA in 2019  In this technique local anesthetics

are administered only to the underside of the perichondrial surface of tenth rib It has been

found that this technique provides a sensory block between T5-T12 dermatomes This has

recently been used for postoperative analgesia in laparoscopic abdominal surgeries because it

is considered to provide effective analgesia in the anterior and lateral thoracoabdominal

wallsThere are limited literature comparing the efficacy of modified  thoracoabdominal nerve blocks M TAPA with

subcostal  transversus abdominis plane blocks STAP therefore further studies are required to conclude the efficacy between the two fascial plane block

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • American Society of Anesthesiologists (ASA) classes I–II patients Patients 18 yrs to 65yrs of age Planned for laparoscopic cholecystectomy of either sex under general anaesthesia.

排除标准

  • ASA III-IV patients Any known drug allergies Contraindication to nerve block like coagulopathy bleeding diathesis and local infections Not giving the consent for the block Inability to understand or use the numerical rating scale and QOR 15 score.

结局指标

主要结局

Median numeric pain rating score NRS in first 24 hours post operatively between thoracoabdominal nerve block and subcostal transversus abdominis block groups .

时间窗: At 0 min 15 min 30 min 1 hour 3 hour 6 hour 12 hour 24hours postoperative

次要结局

  • 1Mean dose in mg opioid consumption in morphine equivalent mgperkg in first 24 hours postoperatively(2 Mean duration of analgesia in minutes)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sania

lady hardinge medical college and associated hospitals

研究点 (1)

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