跳至主要内容
临床试验/NCT07513012
NCT07513012Enrolling By Invitation不适用

Comparison of Efficacy of Unilateral Transversus Abdominis Plane (TAP) Block Versus Bilateral Transversus Abdominis Plane (TAP) Block in Patients Undergoing Laparoscopic Cholecystectomy.

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
82
试验地点
1
主要终点
Mean time to first request for rescue analgesia

研究概览

简要总结

In this study, patients undergoing laparoscopic cholecystectomy will be randomly divided into 2 groups after consent. Group A patients will be administered a one-sided (right unilateral) regional TAP block and group B patients will be administered the same block on both sides (bilateral) and the effects in terms of post surgery pain during the 1st 24 hours, nausea vomiting, and the need and dosage of intravenous analgesic and antiemetic will be studied to see whether one technique is superior to the other or not.

详细描述

  1. INTRODUCTION:

Laparoscopic cholecystectomy (LC) is the gold standard procedure for individuals with symptomatic gallstone disease. Although LC is a minimally invasive procedure with very less morbidity, early post-operative pain still a significant issue.1 Adequate pain control is therefore necessary to improve clinical outcomes, patient satisfaction and to ensure early mobility of the patients. Pain after laparoscopic cholecystectomy can be broadly classified into 3 categories: (a) somatic pain due to skin incisions; (b) Visceral pain due to intra-abdominal gallbladder dissection and; (c) reflected visceral pain or referred pain to the tip of right shoulder. Out of these, the somatic pain from port site incisions is the most troublesome for patients. Various methods have been tried to reduce post-operative pain after LC, one of which is the Transversus abdominis plane (TAP) block. TAP block is a regional anesthesia technique used for post-operative analgesia in abdominal surgeries. TAP block was first described by Rafi et al in 2001, as a regional block, in which local anesthesia is injected through triangle of petit to achieve analgesia of the T6 to L1 thoracolumbar nerves as they pass through the plane between internal oblique and transversus abdominis muscles.5,7,8 This blocks the sensory nerves in the anterolateral abdominal wall. Unilateral TAP block has been used as a part of multimodal analgesia in LC, with favorable results. However, half of the port site incisions in LC are located in the midline, i.e. the subxiphoid epigastric and the umblical ports. So, whether a unilateral TAP block alone provides adequate analgesia or not, cannot be stated as a fact. Although literature compares unilateral vs bilateral TAP in a variety of different surgical procedures, such as cesarean section and laparoscopic shockwave lithotripsy10,11 only one study is available to compare unilateral TAP versus bilateral TAP in LC.

Thus, the rationale of this study is that more research needs to be done to compare unilateral and bilateral TAP blocks in LC so as to establish which of the two is more efficient in providing adequate analgesia and eliminating the need for post-operative intravenous opioids. This will help us to better understand the role of in TAP block in LC. It is expected that this will help in reducing the need and dosage for postoperative IV opioids thus reducing post-operative nausea and vomiting (PONV), improve patient satisfaction and allow early mobilization of the patient. Mayo hospital Lahore is one of the largest government sector hospitals of Punjab with a dedicated surgical facility well equipped to deal with large numbers of patients with symptomatic gallstones. This makes this hospital an ideal set-up for conducting this research. 2. OBJECTIVE:

Primary objective of this study is to compare unilateral and bilateral TAP blocks in terms of efficacy in terms of mean duration of postoperative analgesia and the need and amount of post- operative IV opioids needed. Secondary objectives include comparison of both blocks in terms of PONV, the need and amount of ondensetron, and patient satisfaction. 3. OPERATIONAL DEFINITIONS:

  1. TRANVERSUS ABDOMINIS PLANE (TAP) BLOCK:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders between 18-80 years with symptomatic gallstone disease.
  • Diagnosed patients that are fit for laparoscopic cholecystectomy, having ASA status of I, II or III).
  • No documented allergies or adverse reactions to local anesthetics used.
  • Patients consenting to participate in the study.

排除标准

  • Non consenting individuals.
  • Active skin infection at TAP block site i.e. triangle of petit.
  • Patients with coagulopathies.
  • Patients with chronic pain disorders and chronic use of analgesics.
  • Patients with chronic liver and kidney diseases.
  • Patients with alcohol, opioid or other substance addiction.
  • History of previous major elective or emergency abdominal surgery.
  • Pregnant and breast feeding women.

研究组 & 干预措施

Group A

Active Comparator

Right unilateral TAP block

干预措施: Unilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine (Procedure)

Group B

Experimental

Bilateral TAP block

干预措施: Bilateral Transversus abdominis plane (TAP) block with 0.25 % bupivacaine (Procedure)

结局指标

主要结局

Mean time to first request for rescue analgesia

时间窗: Time from completion of surgery to first request for rescue analgesia till completion of 24 hrs

Time from completion of surgery to first request for rescue analgesia.

The amount of postoperative IV opioids required as rescue analgesia in first 24 hrs

时间窗: From end of surgery up to 24 hours postoperatively.

Total amount of intravenous opioid analgesic (in mg) administered in the first 24 hours after surgery

次要结局

  • Frequency of Postoperative nausea and vomiting (PONV)(From the end of surgery to the end of treatment at 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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