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临床试验/NCT07552701
NCT07552701招募中不适用

Comparison of Ultrasonography-Guided the Postoperative Analgesic Efficacy of Perichondrial Approach Modified Thoracoabdominal Nerve Block and Recto-Intercostal Fascial Plan Block in Patients Who Underwent Laparoscopic Cholecystectomy

Hitit University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Postoperative Opioid Consumption

研究概览

简要总结

Laparoscopic cholecystectomy (LC) can cause moderate-to-severe postoperative pain from visceral, referred shoulder, and incisional sources. Multimodal analgesia is recommended, but opioids carry significant side effects. Ultrasound-guided interfascial plane blocks offer a safe alternative. The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) blocks T5-T12 dermatomes, while the Recto-Intercostal Fascial Plane Block (RIFPB) provides sensory blockade across the upper anterolateral abdomen. This study compares the postoperative analgesic efficacy of bilateral M-TAPA versus bilateral RIFPB in patients undergoing LC.

详细描述

The gallbladder is a small organ located in the right upper quadrant of the abdomen that stores bile, which aids in food digestion. Gallstones form as a result of changes in bile composition caused by hormones, medications, diet, and weight fluctuations. When a gallstone obstructs the cystic duct, acute cholecystitis develops, leading to gallbladder distension and inflammation. Cholecystectomy is the standard surgical treatment performed worldwide for this condition.

Management of acute cholecystitis is either medical - consisting of bed rest, analgesics, antibiotherapy, and intravenous fluid replacement - or surgical, involving removal of the gallbladder. While the procedure can be performed via open or laparoscopic technique, laparoscopic cholecystectomy (LC) is superior in terms of less incisional pain, shorter hospital stay, improved quality of life, and faster recovery.

Despite being minimally invasive, LC can cause moderate-to-severe postoperative pain. The majority originates from incision sites (50-70%), with additional contributions from pneumoperitoneum (20-30%) and the cholecystectomy itself (10-20%). Severe pain leads to delayed mobilization, reduced patient satisfaction, chronic pain development, and increased pulmonary and cardiac complications. A multimodal analgesic approach is therefore recommended. Although NSAIDs, paracetamol, opioids, and local anesthetics are commonly used, opioids carry significant risks including postoperative nausea and vomiting (PONV), constipation, and respiratory depression. Neuraxial analgesia is rarely preferred due to potential complications and technical difficulties.

Ultrasound-guided interfascial plane blocks have gained increasing use in LC due to their safety and efficacy. The anterolateral abdominal wall is composed of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles. The transversus abdominis plane contains the T6-L1 thoracolumbar nerves between the internal oblique and transversus abdominis muscles, and local anesthetic injection into this plane provides T7-L1 sensory blockade.

The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), introduced by Tulgar et al., applies local anesthetic solely to the inferior surface of the costochondral perichondrium at the 9th-10th rib level under ultrasound guidance, targeting T4/T5-T12/L1 thoracoabdominal nerves. It blocks anterior and lateral cutaneous branches to provide abdominal analgesia, with reported efficacy in both minor and major abdominal surgeries.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • ASA physical classification I-II
  • BMI < 35 kg/m²
  • Scheduled for elective laparoscopic cholecystectomy due to cholelithiasis
  • Able to use and understand the NRS pain scoring system
  • Able to use and understand the QoR-15 scale
  • Able to communicate in Turkish
  • Provided written informed consent

排除标准

  • Refusal to participate in the study
  • BMI > 35 kg/m²
  • ASA physical classification III-V
  • Age < 18 or > 65 years
  • Allergy to local anesthetics or study analgesics
  • Pregnancy or breastfeeding
  • Inability to use or understand the NRS pain scoring system or QoR-15 scale
  • Inability to communicate in Turkish
  • Uncontrolled anxiety disorder
  • Alcohol or drug dependency
  • Neuromuscular or peripheral nerve disease
  • High-dose opioid use within 3 days prior to surgery
  • Widespread chronic pain
  • Diabetes mellitus
  • Hepatic or renal insufficiency
  • Coagulation disorders or anticoagulant use
  • Infection at the block needle insertion site
  • Concurrent second surgical procedure alongside laparoscopic cholecystectomy
  • Previous abdominal surgery or trauma history
  • Conversion from laparoscopic to open surgery
  • Technical problems with the PCA device
  • NRS score > 7 for four consecutive hours despite multimodal analgesia
  • Planned postoperative non-extubation
  • Termination of surgery before completion for any reason

研究组 & 干预措施

M-TAPA Group

Active Comparator

M-TAPA Group:

Patients receiving ultrasound-guided bilateral Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) using 20 ml of 0.25% bupivacaine per side, applied at the 10th rib level beneath the costochondral perichondrium after surgery while under anesthesia.

干预措施: M-TAPA Group (Procedure)

RIFPB Group

Active Comparator

RIFPB Group:

Patients receiving ultrasound-guided bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 ml of 0.25% bupivacaine per side, injected into the interfascial plane between the rectus abdominis muscle and the 6th-7th costal cartilages just below the xiphoid process, applied after surgery while under anesthesia.

干预措施: RIFPB Group (Procedure)

结局指标

主要结局

Postoperative Opioid Consumption

时间窗: 24 hours postoperatively

Total tramadol consumption (mg) via patient-controlled analgesia (PCA) recorded at 0-1, 1-12, 12-24 hours, and total 24 hours postoperatively.

次要结局

未报告次要终点

研究者

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

Hakan AKEL

Principal Investigator

Hitit University

研究点 (1)

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