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临床试验/NCT07021105
NCT07021105Enrolling By Invitation不适用

COMPARISON OF ERECTOR SPINAE PLANE BLOCK, QUADRATUS LUMBORUM BLOCK, AND TRANSVERSUS ABDOMINIS PLANE BLOCK IN POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES

Cukurova University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
80
试验地点
1
主要终点
morphine consumption in the postoperative period

研究概览

简要总结

This study compares the effects of transversus abdominis plane (TAP) block, quadratus lumborum block (QLB), and erector spinae plane block (ESP) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries.

详细描述

Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group:

Group E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.

Group Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.

Group T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.

Group C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •aged between 18 and 69 years, with ASA 1-2 score scheduled to undergo major gynecological abdominal surgery

排除标准

  • •ASA score 3 or above, patients younger than 18 or older than 69 years, patients with bleeding disorders or using anticoagulants, patients with a body mass index over 40, patients with known allergies to any drugs used in the study, and patients who could not or did not wish to use Patient-Controlled Analgesia (PCA) device

研究组 & 干预措施

Group Q

Active Comparator

Group QLB & ESP, TAP, Control

干预措施: ESP Plane block (Procedure)

Group Q

Active Comparator

Group QLB & ESP, TAP, Control

干预措施: TAP Block (Procedure)

Group T

Active Comparator

Group T & ESP, QLB, Control

干预措施: ESP Plane block (Procedure)

Group T

Active Comparator

Group T & ESP, QLB, Control

干预措施: QLB plane block (Procedure)

Group C

No Intervention

Group C & ESP, QLB, TAP

Group E

Active Comparator

Group ESP & QLB, TAP, Control

干预措施: QLB plane block (Procedure)

Group E

Active Comparator

Group ESP & QLB, TAP, Control

干预措施: TAP Block (Procedure)

Group T

Active Comparator

Group T & ESP, QLB, Control

干预措施: No intervention (Other)

Group Q

Active Comparator

Group QLB & ESP, TAP, Control

干预措施: No intervention (Other)

Group E

Active Comparator

Group ESP & QLB, TAP, Control

干预措施: No intervention (Other)

结局指标

主要结局

morphine consumption in the postoperative period

时间窗: For postoperative 24 hours

Thus the primary aim of this study was to assess the morphine consumption in the postoperative period

次要结局

  • pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects(For postoperative 24 hours)

研究者

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

Hakki Unlugenc

Prof Dr

Cukurova University

研究点 (1)

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