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临床试验/NCT06017401
NCT06017401已完成不适用

Comparison of The Effect of Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Analgesia and Quality of Recovery in Patients Undergoing Laparoscopic Gynecological Surgery

Uludag University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2023年5月22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
68
试验地点
2
主要终点
Postoperative 24 hours total analgesic consumption

研究概览

简要总结

Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular quadratus lumborum block (TQLB).

详细描述

Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery, American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB group and TQL block will be performed for TQLB group. Patients will be administered postoperative 4x500 mg iv paracetamol as needed (if Visual Analogue Scale (VAS) score is 4 or higher). If the VAS score remains at 4 or higher 30 minutes after paracetamol administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption within the first 24 hours after surgery. The secondary outcome is to compare the time to the first postoperative analgesic requirement, VAS scores at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QOR-15 scale

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages of 18-65
  • Patients who will undergo laparoscopic gynecological surgery
  • ASA I-II-III patients
  • Body Mass Index (BMI) in the range of 18-25 kg/m²
  • Patients who will undergo surgery using 3 or 4 trocars

排除标准

  • Patients with a known or suspected allergy to local anesthetics
  • Coagulopathy
  • Injection site infection
  • Severe neurological or psychiatric disorders
  • Severe cardiovascular disease
  • Liver failure
  • Kidney failure (glomerular filtration rate <15 ml/min/m²)
  • Chronic opioid use (>6 months)
  • Surgical durations less than 45 minutes or greater than 120 minutes

研究组 & 干预措施

Group OSTAP

Active Comparator

The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia

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

Group TQLB

Active Comparator

The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia

干预措施: Transmuscular Quadratus Lumborum Block (Procedure)

结局指标

主要结局

Postoperative 24 hours total analgesic consumption

时间窗: 24 hours postoperatively

The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.

次要结局

  • The time to the first analgesic requirement, VAS scores and QOR-15 scores of the patients(24 hours postoperatively)

研究者

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

Kübra Cebeci

Research Assistant

Uludag University

研究点 (2)

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