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临床试验/NCT06482229
NCT06482229已完成不适用

Postoperative Analgesic Efficacy of Intraperitoneal Bupivacaine, Bupivacaine and Dexmedetomidine With Modified-Pericondrial Approach Thoracoabdominal Nerve Block (M-TAPA) in Laparoscopic Cholecystectomy Surgeries

Sivas State Hospital2 个研究点 分布在 2 个国家目标入组 51 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
2
主要终点
pain scores

研究概览

简要总结

Laparoscopic cholecystectomy is a common abdominal surgery in Western countries, favored for its minimal invasiveness, leading to less pain, smaller scars, and quicker recovery. Despite its benefits, it is contraindicated in cases of bleeding disorders, peritonitis, hemodynamic instability, severe heart failure, and advanced COPD. Effective postoperative pain management is crucial for faster recovery, shorter hospital stays, and lower costs, using techniques such as intravenous or intramuscular analgesics, epidural analgesia, and local anesthetic injections like TAP block or M-TAPA block. The TAPA block, introduced in 2019, involves applying local anesthetic to the costochondral junction, affecting thoracoabdominal nerves, with a modified version (M- TAPA) applying anesthetic to the lower surface only. Studies have shown M-TAPA's efficacy in reducing pain and analgesic use postoperatively. Postoperative pain from laparoscopic cholecystectomy mainly arises from inflammation in the gallbladder bed and pneumoperitoneum. This study aims to evaluate the postoperative analgesic efficacy of intraperitoneal bupivacaine, bupivacaine with dexmedetomidine, and M-TAPA block by assessing pain scores and analgesic consumption in a prospective, randomized, double- blind trial with 45 patients. Patients will be assigned to three groups: M- TAPA block, intraperitoneal bupivacaine, and intraperitoneal bupivacaine with dexmedetomidine, with an experienced anesthetist administering the blocks and evaluating outcomes to compare these pain management techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Laparoscopic cholecystectomy surgery planned
  • ASA #-II-III classification
  • Willingness to participate in the study

排除标准

  • Bleeding disorders
  • Signs of infection at the block application site
  • Conversion to open surgery
  • Allergy to local anesthetics
  • Unstable hemodynamics
  • Inability to provide informed consent

结局指标

主要结局

pain scores

时间窗: Time Frame: 24 hours after the procedure

zero meaning "no pain" and 10 meaning "the worst pain imaginable

次要结局

  • total analgesic consumption(24 hours after the procedure)

研究者

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

Fatih Balcı

Specialist/Department of Anaesthesiology and Reanimation

Sivas State Hospital

研究点 (2)

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