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临床试验/NCT07661576
NCT07661576尚未招募不适用

Targeted Management of Somatic Pain in Laparoscopic Cholecystectomy: A Prospective Comparison of Lateral and Subcostal TAP Block Approaches for Drain-Site Analgesia

Turgut Ozal University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2026年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
Drain-Site Pain Score at 6 Hours Postoperatively

研究概览

简要总结

Laparoscopic cholecystectomy is a commonly performed surgical procedure. Despite its minimally invasive nature, patients may experience significant postoperative pain, particularly at trocar insertion sites and surgical drain entry sites. Pain originating from the drain site is often localized to the lateral abdominal wall and may contribute substantially to postoperative discomfort.

Transversus abdominis plane (TAP) block is a regional anesthesia technique widely used for postoperative pain management after abdominal surgery. Different TAP block approaches provide analgesia to different regions of the abdominal wall.

This prospective randomized clinical trial aims to compare two TAP block strategies in patients undergoing laparoscopic cholecystectomy with surgical drain placement. Patients will be randomly assigned to receive either bilateral subcostal TAP block or a targeted approach consisting of a lateral TAP block on the drain side and a subcostal TAP block on the opposite side.

The primary outcome is postoperative drain-site pain intensity measured using the Numeric Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include pain scores at additional postoperative time points, opioid consumption, time to first analgesic request, patient satisfaction, postoperative nausea and vomiting, sedation scores, and recovery parameters.

The findings of this study may help identify a more effective regional analgesia strategy for the management of drain-site pain following laparoscopic cholecystectomy.

详细描述

Introduction Laparoscopic cholecystectomy is one of the most frequently performed surgical procedures for the treatment of gallbladder diseases. Although it is considered a minimally invasive technique, patients may still experience significant postoperative pain. This pain has both visceral and somatic components, with somatic pain being particularly prominent at trocar incision sites and surgical drain entry sites.

Effective management of postoperative pain is crucial for enhancing patient comfort, promoting early mobilization, and shortening hospital stay. Therefore, multimodal analgesia protocols and opioid-sparing regional anesthesia techniques are increasingly being incorporated into perioperative care. The transversus abdominis plane (TAP) block is a widely used regional analgesia technique that targets the somatic innervation of the anterior abdominal wall and has demonstrated efficacy in reducing postoperative pain and opioid requirements following abdominal surgery [1][2] .

The transversus abdominis plane (TAP) block can be performed using different ultrasound-guided approaches, including the lateral, posterior, and subcostal techniques. These approaches differ in their dermatomal coverage and duration of analgesia. The lateral TAP block is performed by injecting a local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles under ultrasound guidance. This technique aims to provide temporary blockade of the T6-L1 spinal nerve branches that supply somatic innervation to the anterior abdominal wall. It is widely used for postoperative pain management following lower and lateral abdominal procedures, including cesarean section, gynecological surgery, appendectomy, laparoscopic abdominal surgery, and inguinal hernia repair [1]. Previous studies have demonstrated that TAP block can provide prolonged postoperative analgesia and significantly reduce both opioid consumption and pain scores, particularly during the first 12-48 hours after surgery [3,4].

Similarly, randomized controlled trials have demonstrated that TAP block techniques can reduce postoperative pain scores and decrease opioid requirements [5]. Consequently, TAP blocks have become an important component of multimodal analgesia protocols in laparoscopic surgery [1]. However, most studies in the current literature have focused on overall postoperative pain and opioid consumption, while specific sources of postoperative pain have rarely been evaluated separately.

In patients undergoing surgical drain placement, the drain insertion site has been clinically recognized as a distinct source of somatic pain, particularly involving the lateral abdominal wall. Despite its clinical relevance, studies specifically investigating analgesic strategies targeting drain-related pain remain scarce. Most available studies have evaluated global pain scores and opioid consumption, whereas localized outcomes such as drain-site pain have seldom been assessed.

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
Double (Participant, Outcomes Assessor)

盲法说明

The anesthesiologist performing the block procedures will be aware of treatment allocation because of the nature of the intervention. However, participants and the investigator responsible for postoperative outcome assessment will remain blinded to group assignment throughout the study. Pain assessments and data collection will be performed by a blinded outcomes assessor.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-75 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) < 35 kg/m², undergoing elective laparoscopic cholecystectomy and requiring abdominal drain placement at the end of surgery.

排除标准

  • Patients with known allergy to local anesthetics, coagulopathy or ongoing anticoagulant therapy, infection at the planned block site, chronic opioid use, chronic pain syndromes, pregnancy, severe hepatic or renal insufficiency, inability to communicate effectively or to perform pain assessment using the Numeric Rating Scale (NRS), previous upper abdominal surgery, or drain placement outside the lateral abdominal wall (e.g., subxiphoid location) will be excluded. Patients who require conversion to open surgery, postoperative intensive care unit admission, or who experience block failure will also be excluded from the final analysis.

研究组 & 干预措施

Group S (Standard Group)

Active Comparator

Participants will receive an ultrasound-guided bilateral subcostal transversus abdominis plane (TAP) block at the end of surgery prior to extubation. A total of 40 mL of 0.25% bupivacaine (20 mL per side) will be administered to provide standard postoperative analgesia of the upper abdominal wall.

干预措施: Bilateral Subcostal TAP Block (Procedure)

Group L (Targeted Group)

Active Comparator

Participants will receive an ultrasound-guided lateral TAP block on the side of surgical drain placement and a subcostal TAP block on the contralateral side. A total of 40 mL of 0.25% bupivacaine (20 mL at each injection site) will be administered. This targeted approach is intended to provide enhanced analgesia at the drain insertion site while maintaining upper abdominal wall analgesia.

干预措施: Lateral TAP Block Plus Contralateral Subcostal TAP Block (Procedure)

结局指标

主要结局

Drain-Site Pain Score at 6 Hours Postoperatively

时间窗: 6 hours after surgery

Pain intensity at the surgical drain insertion site measured using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).

次要结局

未报告次要终点

研究者

发起方
Turgut Ozal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

haci osman toplu

Principal Investigator

Turgut Ozal University

研究点 (1)

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