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临床试验/NCT06934772
NCT06934772已完成不适用

Comparison of the Analgesic Efficacy of Subcostal Transversus Abdominis Plane and Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Blocks in Laparoscopic Sleeve Gastrectomy Surgery

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 41 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
已完成
发起方
入组人数
41
试验地点
1
主要终点
Analgesic Efficacy

研究概览

简要总结

Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a Body mass index (BMI) greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).

详细描述

Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).

Study Design This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a BMI greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).

Study Procedures Patients who meet the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.

Outcome Measures

  • Primary Outcome: Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods (first 24 hours).
  • Secondary Outcomes: Resting and active NRS pain scores, mobilization times, incidence of nausea and vomiting, and complications related to the block procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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
否

入选标准

  • •patients with a BMI greater than 35 kg/m²,
  • •aged between 18 and 65, who are scheduled to undergo LSG surgery.
  • •Patients will receive either a subcostal TAP or M-TAPA block before surgery.

排除标准

  • •patients with incomplete data
  • •patients with chronic pain
  • •patients with preoperative opioid use
  • •patients with preoperative alcohol/substance use

结局指标

主要结局

Analgesic Efficacy

时间窗: Intraoperative periods, postoperative first 24 hours.

Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods.The visual pain score includes values between 0 and 10. o means no pain, 5 means moderate pain, and 10 means severe pain. In the postoperative period, the pain levels of the patients will be compared by looking at this visual pain value. In the intraoperative period, the amount of analgesic consumption (total consumption of remifentanil mcg) will be evaluated.

次要结局

  • Other conditions associated with the block(postoperative 24 hours)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Munevver Kayhan

Lecturer doctor

Istanbul University - Cerrahpasa

研究点 (1)

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