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临床试验/NCT07465406
NCT07465406已完成不适用

Comparison Of Patients Post Operative Pain Undergoing Laparoscopic Cholecystectomy Receiving Tap Block Vs Not Receiving Tap Block

Darul Sehat Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visual Analog Scale (VAS) Score for Pain

研究概览

简要总结

This study compares the effectiveness of a Transversus Abdominis Plane (TAP) block in reducing post-operative pain for patients undergoing laparoscopic cholecystectomy. Sixty patients were divided into two groups: one group received a TAP block with a local anesthetic at the end of surgery, and the control group did not. The main goal was to see if the TAP block significantly lowers pain scores (measured on a scale of 0 to 10) within the first 12 hours after surgery and if it reduces the need for additional pain-relief medications.

详细描述

Laparoscopic cholecystectomy is the gold standard for treating symptomatic cholelithiasis; however, patients often experience significant in the early post-operative period. This randomized controlled trial (RCT) was conducted at the Department of Surgery, Liaquat College of Medicine & Dentistry, Karachi, to evaluate the analgesic efficacy of the TAP block.

A total of 60 patients, aged 18-60 years with ASA I or II, were randomized into two equal groups (n=30 each). The intervention group received an TAP block while the control group received standard post-operative analgesia.

The primary objective was to compare the mean Visual Analog Scale (VAS) score at 12 hours post-operation. Secondary objectives included assessing the time to the first request for rescue analgesia and the type of analgesic drug used. Data were analyzed to determine if the TAP block provides superior pain control compared to conventional methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-60 years
  • Both genders
  • Patients diagnosed with Cholelithiasis in accordance with operational definition and planned to undergo Laparoscopic Cholecystectomy

排除标准

  • Patients with ASA of ≥ 3
  • Patients diagnosed with acute cholecystitis, empyema, mucocele or perforated gall bladder
  • Patients planned to undergo laparoscopic cholecystectomy alongside other abdominal procedures
  • Patients with body mass index of ≥ 35 Kg/m2
  • Patients with history of coagulation disorders like hemophilia or those with history of anti-platelet drugs use in last 2 weeks
  • Pregnant females

研究组 & 干预措施

TAP Block Group

Experimental

Patients in this group received a Transversus Abdominis Plane (TAP) block at the end of the laparoscopic cholecystectomy but before extubation.

干预措施: Bupivacaine 0.25% (Drug)

Control Group (The No TAP Block Group)

Other

Patients in this group underwent laparoscopic cholecystectomy under the same general anesthesia protocol but did not receive a TAP block

干预措施: Standard Post-Operative Care (Other)

结局指标

主要结局

Visual Analog Scale (VAS) Score for Pain

时间窗: 12 hours post-operation

A subjective psychometric response scale used to measure pain intensity. It consists of a 10 cm line where 0 represents "no pain" and 10 represents "the worst pain imaginable.".

次要结局

  • Time for First Request of Rescue Analgesia(Within the first 24 hours post-operation.)

研究者

发起方
Darul Sehat Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

SARAH RAUF

Surgical Resident -FCPS Trainee

Darul Sehat Hospital

研究点 (1)

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