跳至主要内容
临床试验/NCT06841783
NCT06841783已完成不适用

Ultrasound-Guided Erector Spinae Plane Block Versus Modified Thoracoabdominal Nerve Block for Perioperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. A Randomized Comparative Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月24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
40
试验地点
1
主要终点
Time to first rescue analgesia

研究概览

简要总结

Obesity is a complex chronic disease that has become a major public health concern worldwide, with the prevalence of obesity increasing dramatically over the past few decades. Patients with morbid obesity pose a challenge for perioperative pain management. High ceiling analgesics-opioids have limited role due to safety concerns for patients with or without obstructive sleep apnea .

Insufficient postoperative pain management can have negative effects on recovery and quality of life, as well as limit patient comfort and delay the patient's ability to return to work after surgery .

Due to the numerous negative side effects of opioid drugs, including physical dependence, nausea, vomiting, and respiratory depression and subsequent airway obstruction, the Enhanced Recovery after Surgery (ERAS) guidelines for bariatric surgery currently advise opioid reduction in this procedure.

Ultrasound-guided erector spinae plane block (ESPB) and modified thoracoabdominal nerve block (M-TAPA) are both regional anesthesia techniques used to provide perioperative analgesia for obese patients undergoing LSG .

The ESPB targets the spinal nerves as they exit the erector spinae muscle, providing analgesia to the abdominal wall and paraspinal muscles. The technique has shown promising results in various surgical procedures and has a low risk of complications. By blocking the spinal nerves, the ESPB can provide effective pain relief in the postoperative period for patients undergoing LSG .

On the other hand, the M-TAPA targets the thoracic intercostal nerves and the abdominal wall, providing analgesia to these areas. The technique has been shown to provide effective perioperative analgesia in patients undergoing LSG. With or without ultrasound guidance, the use of M-TAPA can provide effective pain relief and reduce the need for opioid medication in the postoperative period.

This study aimed to compare the analgesic effect of ultrasound guided modified thoracoabdominal nerve block and an erector spinae plain block in patients undergoing LGS

详细描述

Patients will be randomly allocated into two groups: ESPB (n=20) and M TAPA (n=20).

  1. ESPB group: This group will receive ultrasound guided erector spinae plane block.
  2. M-TAPA group: This group will receive ultrasound guided modified thoracoabdominal nerve block.

Preoperative assessment:

The patient will enter the preparation room, he/she will be asked about his medical and surgical history in details and fasting hours (6-8 hrs) and full examination will be performed including airway examination. Lab investigations including complete blood count (CBC), coagulation profile, liver function tests and renal function tests will be checked.

The procedure will be explained to the patient and informed consent will be signed after his agreement then the patient will be classified into one of the groups.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
是

入选标准

  • •1. ASA II & ASA III.
  • •Gender both males and females
  • •Age group: from 18 to 65 years old

排除标准

  • •• Patient refusal.
  • •Uncooperative patients.
  • •Allergy to local anesthetics.
  • •Anatomical abnormality at injection site.
  • •Redo or combined cholecystectomy surgery.
  • •Infection at injection site.

研究组 & 干预措施

Erector Spinae Plane Block

Experimental

Ultrasound-Guided Erector Spinae Plane Block

干预措施: nerve block (Procedure)

Modified Thoracoabdominal Nerve Block

Experimental

Ultrasound-Guided Modified Thoracoabdominal Nerve Block

干预措施: nerve block (Procedure)

结局指标

主要结局

Time to first rescue analgesia

时间窗: the first 24 hours postoperatively

it is defined as time from extubation until time to first analgesic requirement during the first 24 hours postoperatively.

次要结局

  • The total opioid consumption(the first 24 hours postoperatively)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed nabih youssef

lecturer of anesthesia

Kasr El Aini Hospital

研究点 (1)

Loading locations...

相似试验