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临床试验/NCT06662617
NCT06662617招募中不适用

Comparison of the Effects of M-TAPA and TAP Nerve Block Applications on Postoperative Pain Scores and Analgesia Requirements in Laparoscopic Cholecystectomy

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
numerical rating scale scores

研究概览

简要总结

Cholecystectomy is the most frequently performed abdominal surgery in developed nations, with laparoscopic cholecystectomy being recognized as the gold standard technique for treating gallstones.

The efficacy of TAP block for pain relief has been well-documented following laparoscopic cholecystectomy procedures. Recently, m-TAPA block has emerged as an alternative analgesic technique for abdominal surgeries.

This study aims to evaluate and compare the effectiveness of these two analgesic methods in managing postoperative pain after laparoscopic cholecystectomy.

详细描述

Cholecystectomy is the most commonly performed abdominal surgery in developed countries, with laparoscopic cholecystectomy regarded as the gold standard technique for gallstone treatment.

Postoperative pain following laparoscopic cholecystectomy is influenced by several factors, making it a complex and predominantly visceral pain. These factors include phrenic nerve irritation due to CO2 insufflation, abdominal distension, port site incisions, the effects of gallbladder removal, and individual patient characteristics.

Regional analgesia has gained widespread acceptance from both patients and physicians, becoming a key component of multimodal analgesia techniques. The transversus abdominis plane (TAP) block has proven effective in reducing postoperative pain in surgeries such as hysterectomy, cholecystectomy, cesarean section, and colorectal procedures.

The Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) involves administering a local anesthetic to the underside of the perichondral surface. This technique provides effective analgesia for the anterior and lateral thoracoabdominal regions.

The purpose of this study is to compare the efficacy of US-guided M-TAPA block with TAP block for postoperative analgesia following cholecystectomy.

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 patient and the outcomes assessor who performs postoperative pain evaluation will not know the group

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

  • Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of
  • Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

排除标准

  • Patients who did not give consent,
  • patients with coagulopathy,
  • patients with signs of infection at the block application site,
  • patients using anticoagulants,
  • patients with local anesthetic drug allergies,
  • patients undergoing open surgery,
  • patients with unstable hemodynamics,
  • patients who could not cooperate during postoperative pain assessment

结局指标

主要结局

numerical rating scale scores

时间窗: postoperative 24 hours

numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

次要结局

  • total tramadol consumption(postoperative 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hüseyin Özden

associate professor

Cumhuriyet University

研究点 (1)

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