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临床试验/NCT06778629
NCT06778629已完成不适用

Evaluation of the Effectiveness of Transversalis Fascia Plane Block in Patients Undergoing Laparoscopic Inguinal Hernia Repair

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2月14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
60
试验地点
1
主要终点
Rescue analgesic use

研究概览

简要总结

Transversalis Fascia Plane Block (TFPB) is a trunk block that blocks the T12- L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall. The block's positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open-technique inguinal hernia repair.

This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

详细描述

Inguinal hernia repairs are one of the most common general surgical operations and are generally performed with laparoscopic technique. Even laparoscopic inguinal hernia repair results in less acute postoperative pain compared to the open technique, untreated early pain may prolong hospital stay, exacerbate general discomfort, and affect the length of recovery, which may also have social and -economic implications. 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, 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.

Transversalis Fascia Plane Block (TFPB) is a body block that blocks the T12-L2 spinal nerves by injection of local anesthetic between the transversus abdominis muscle and transversalis fascia on the lateral abdominal wall Its positive effects on postoperative analgesia have been shown in many abdominal surgeries, including open technique inguinal hernia repair.

This study aimed to investigate the effectiveness of ultrasound (US) guided TFPB on postoperative pain control for postoperative analgesia management after laparoscopic inguinal hernia repair.

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
否

入选标准

  • •American Society of Anesthesiologists (ASA) classification I- II Patients
  • •Unilateral Inguinal Hernia Repair Surgery
  • •Elective Operations

排除标准

  • •Patients with a history of chronic pain
  • •Evidence of infection in the intervention area
  • •Allergy to local anesthetics
  • •Coagulopathy
  • •Body-mass index (BMI) ≥ 30
  • •Body weight ≤ 50 kg
  • •Patients who do not agree to participate in the study

研究组 & 干预措施

Group K = Control group

Active Comparator

Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. No plane block will be applied.

干预措施: Post Operative Pain Management (Procedure)

Group K = Control group

Active Comparator

Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied. No plane block will be applied.

干预措施: Port Site Infiltration (Procedure)

Group T = TFPB group

Experimental

Transversalis Fascia Plane block will be performed. Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied.

干预措施: Post Operative Pain Management (Procedure)

Group T = TFPB group

Experimental

Transversalis Fascia Plane block will be performed. Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied.

干预措施: Transversalis Fascia Plane Block (Procedure)

Group T = TFPB group

Experimental

Transversalis Fascia Plane block will be performed. Local anesthetic infiltration to port entrance sites at the beginning of the operation and standard postoperative pain management protocols will be applied.

干预措施: Port Site Infiltration (Procedure)

结局指标

主要结局

Rescue analgesic use

时间窗: Need for rescue analgesics at 1, 3, 6, 12,18, and 24 hours postoperatively.

The primary aim is to compare the rescue analgesia amount and its time used in the postoperative 24-hour period

次要结局

  • Compare postoperative pain scores (NRS scores)(NRS scores at rest and while moving will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively.)
  • Side effects and complications(Side effects and complications will be evaluated and recorded at 1, 3, 6, 12,18, and 24 hours postoperatively)

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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