跳至主要内容
临床试验/NCT07522853
NCT07522853已完成不适用

Laparoscopic Inguinal Hernia Surgery Patients: Comparison of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Oblique Subcostal TAP Block for Postoperative Analgesia

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Total analgesic consumption in 24 hours

研究概览

简要总结

This randomized controlled trial aims to compare the postoperative analgesic efficacy of M-TAPA block and OSTAP block in patients undergoing laparoscopic inguinal hernia repair. Pain scores, analgesic consumption, and patient satisfaction will be evaluated.

详细描述

Prospective, randomized, single-blind, controlled study including 90 patients undergoing elective laparoscopic inguinal hernia repair. Patients will be randomized into three groups: M-TAPA, OSTAP, and control. Postoperative pain scores (VAS), analgesic consumption, time to first analgesic requirement, and patient satisfaction will be assessed over 24 hours.

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
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

  • Patients aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective laparoscopic inguinal hernia repair (TEP technique)
  • Ability to understand and use the Visual Analog Scale (VAS)
  • Provided written informed consent

排除标准

  • Refusal to participate or inability to provide informed consent
  • Age under 18 or over 65 years
  • ASA physical status ≥ III
  • Coagulopathy (including abnormal INR, thrombocytopenia, or platelet dysfunction)
  • Infection at the injection site
  • Known allergy or hypersensitivity to study medications (local anesthetics, NSAIDs, opioids)
  • Chronic opioid use (longer than 4 weeks)
  • Use of psychiatric medications affecting pain perception
  • Inability to cooperate or communicate effectively
  • Requirement for postoperative intensive care

研究组 & 干预措施

M-TAPA

Experimental

Bilateral M-TAPA block applied after surgery

干预措施: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) (Procedure)

OSTAP

Experimental

Bilateral OSTAP block applied after surgery

干预措施: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) (Procedure)

CONTROL

Other

No block applied and standart analgesia procedure

干预措施: Standard Analgesia use (paracetamol, contramal) (Other)

结局指标

主要结局

Total analgesic consumption in 24 hours

时间窗: 24 hours postoperative

Total amount of dexketoprofen consumed in the first 24 hours after surgery

次要结局

  • Postoperative Pain Intensity (VAS Score)(0 (15 minutes), 2, 4, 8, 12, 16, and 24 hours postoperative)
  • Time to First Analgesic Requirement(Within 24 hours postoperative)
  • Tramadol Consumption(24 hours postoperative)
  • Patient Satisfaction Score(24 hours postoperative)
  • Incidence of Postoperative Nausea and Vomiting(24 hours postoperative)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Emre Yilmaz

MD, Resident in Anesthesiology and Reanimation

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (1)

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