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临床试验/CTRI/2025/07/090618
CTRI/2025/07/090618招募中4 期

Subcostal versus Posterior approach of ultrasound guided transverse abdominis plane block for postoperative analgesia following laparoscopic cholecystectomy: A Randomised controlled trial

University College of Medical Sciences and GTB Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Duration of postoperative analgesia (defined as time to request of first analgesic along with reported pain score of 4 or more in postoperative period after surgery).

研究概览

简要总结

There is scanty data comparing the subcostal versus posterior approach of TAP block after laparoscopic cholecystectomy.

AIM: To compare postoperative analgesic efficacy of subcostal and posterior approach of ultrasound guided TAP block following laparoscopic cholecystectomy, with dexamethasone as an adjuvant to local anaesthetics.

**Primary Objective:**To compare the duration of analgesia (time to first postoperative analgesic request) following ultrasound guided subcostal versus posterior approach TAP block in patients undergoing laparoscopic cholecystectomy.; using levobupivacaine (0.25%, 15 ml each side) along with dexamethasone (4 mg each side) in both groups.

**Secondary Objective:**To evaluate and compare the following in both groups:

  1. NRS score (pain) at 2 hour, 6 hour, and 24 hours after surgery.

  2. Total dose of paracetamol required in 24 hours after surgery.

  3. Total dose of tramadol (rescue analgesic) required in 24 hours after surgery.

Methodolgy: The anaesthetic management for all patients in either cohort will be standardized as per routine practice. The ultrasound-guided TAP block will be performed using a linear high frequency 6–11 MHz probe. In the subcostal-TAP block, the external oblique, internal oblique and transverse abdominis muscles will be visualized at the anterior axillary line, between the 12th rib and the iliac crest. In contrast, in the posterior-TAP block the transducer will be placed in axial plane in the midaxillary line and moved posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles. After successful extubation, patient will be shifted to post-operative ward. Postoperative multimodal analgesia will be provided using the routine technique in our institution (paracetamol 10 mg/kg i.v., every 6 hours). If at any time in the first 24 hours after surgery patient complains of pain, with a Numeric Rating Scale (NRS) score > 3, rescue analgesia will 4 be provided with tramadol (50 mg i.v.). The NRS score will be graded on a scale of 0-10, where 0 represents no pain and 10 represents the worst imaginable pain.

Statistical Analysis: Statistical analysis will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Intergroup comparison of data will be done using unpaired t-test (normally distributed quantitative data), or Mann-Whitney (non-normally distributed quantitative data), or Chi-square/Fishers exact test (qualitative data). A value of p < 0.05 will be considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
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

  • Consenting patients aged 18-65 years of ASA status 1/2/3 scheduled for Laparoscopic cholecystectomy surgery under General Anaesthesia.

排除标准

  • Pregnant, obese, evidence of infection at site of injection.

结局指标

主要结局

Duration of postoperative analgesia (defined as time to request of first analgesic along with reported pain score of 4 or more in postoperative period after surgery).

时间窗: From end of surgery till the time when patient complains of pain after surgery, with a pain score of 4 or more.

次要结局

  • NRS score for pain (0 to 10)(2. Total paracetamol dos ein 24 hours after surgery)

研究者

发起方
University College of Medical Sciences and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Asha Tyagi

UCMS and GTB Hospital

研究点 (1)

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