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临床试验/NCT06515691
NCT06515691招募中不适用

Evaluation of Effectiveness of Ultrasound-Guided Modified Thoracoabdominal Nerve Plane Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia Management in Patients Undergoing Laparoscopic Sleeve Gastrectomy Operation

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.

详细描述

LSG is defined as first-line bariatric surgery for patients at high surgical risk with better surgical outcomes. Effective postoperative pain management is essential for early mobilization, and reduction of the risk of morbidity and mortality. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications such as atelectasis and impaired alveolar gas exchange, apnea; postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.

Additionally, reducing postoperative opioid consumption helps to provide hemodynamic stability and promote early mobilization. Studies are showing M-TAPA block to be effective for postoperative analgesia for abdominal surgeries, and some studies continued comparing its effect in laparoscopic sleeve gastrectomy with other plane blocks. There are also case reports showing the effectiveness of the M-TAPA block in LSG patients. M-TAPA block's effect on LSG patients has not been studied yet. The investigators hypothesize that the M-TAPA block performed in patients undergoing laparoscopic sleeve gastrectomy would reduce opioid consumption in the first 24-hour period after surgery.

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 outcomes assessor and participants will be blinded to the study.

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

  • American Society of Anesthesiologists (ASA) classification II- III Patients Scheduled for LSG under general anesthesia

排除标准

  • with a history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • with allergies or sensitivity to drugs used,
  • with an infection on the puncture site
  • with a history of alcohol or drug addiction,
  • with congestive heart failure
  • with liver or kidney disease
  • who do not accept the procedure or participate in the study

结局指标

主要结局

Opioid consumption

时间窗: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hours

The primary aim is to compare postoperative opioid consumption from the PCA device.

次要结局

  • Pain scores(Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours)
  • Adverse events(Postoperative 24-hour period)
  • Need for rescue analgesia (tramadol)(Postoperative 24-hour period)

研究者

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

Ayse Ince

Assist Prof

Istanbul Medipol University Hospital

研究点 (1)

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