跳至主要内容
临床试验/NCT04920994
NCT04920994已完成不适用

Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Comparison to Subcostal Transverse Abdominis Plane Block (TAP) in Major Abdominal Surgeries

Sameh Fathy1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Sameh Fathy
入组人数
80
试验地点
1
主要终点
Total analgesic requirements of morphine

研究概览

简要总结

This study will be conducted to evaluate efficacy of ultrasound guided modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) for postoperative analgesia in major abdominal surgeries in comparison to subcostal transverse abdominis plane (SCTAP) block.

It is hypothesized that M-TAPA block will be advantageous to SCTAP block as a promising effective alternative for analgesia for major abdominal surgeries with fewer side effects.

详细描述

Postoperative pain management for major abdominal surgeries can reduce postoperative respiratory dysfunction and promote early mobilization. Traditionally, opioids have been used to manage postoperative pain. However, an increasing awareness of opioid-related adverse events including respiratory depression, paralytic ileus, and sedation, has led to a shift towards utilizing opioid-sparing techniques for postoperative analgesia. As such, outcomes associated with the transverse abdominis plane block are of increasing interest. A modified thoracoabdominal nerves block via a new perichondrial approach (M-TAPA) is a novel analgesic technique that involves local anesthetic injection into the lower aspect of the chondrium. It can block thoracoabdominal nerves at T5 in cephalic direction and down to T11-T12 in caudal direction and may be an effective analgesic for major abdominal surgeries.

The aim of this study is to assess the quality of pain relief in patients who will undergo major abdominal surgery receiving either (M-TAPA) block or (SCTAP) block by comparing and evaluating the differences between the two techniques.

This prospective, randomized, comparative clinical study will include 80 patients who will be scheduled for major abdominal surgery under general anesthesia in Mansoura university hospitals. Informed written consent will be obtained from all subjects in the study after ensuring confidentiality. Eligible patients will be randomly assigned to 2 equal groups (M-TAPA group and SCTAP group) according to computer-generated table of random numbers using the permuted block randomization method. The collected data will be coded, processed, and analyzed using SPSS program. All data will be considered statistically significant if P value is ≤ 0.05.

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)

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

  • American Society of Anesthesiology (ASA) I and II patients.
  • Scheduled for elective major abdominal surgeries.

排除标准

  • Patient's refusal.
  • Altered mental status or un-cooperative patients.
  • History of known sensitivity to the used anesthetics.
  • Bleeding or coagulation diathesis.
  • Infection at the injection site.

研究组 & 干预措施

Group A (M-TAPA )

Active Comparator

Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

干预措施: M-TAPA block (Procedure)

Group A (M-TAPA )

Active Comparator

Ultrasound-guided M-TAPA block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

干预措施: Bupivacaine Hydrochloride (Drug)

Group B (SCTAP)

Active Comparator

Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

干预措施: SCTAP block (Procedure)

Group B (SCTAP)

Active Comparator

Ultrasound-guided SCTAP block will be performed under strict aseptic conditions with the patient in the supine position, and bupivacaine will be administered.

干预措施: Bupivacaine Hydrochloride (Drug)

结局指标

主要结局

Total analgesic requirements of morphine

时间窗: Up to 24 hours after the procedure

The amount of morphine consumption in milligrams given as a rescue analgesia

次要结局

  • Duration for the first analgesic request(Up to 24 hours after the procedure)
  • Improvement in pain scores by Visual analogue scale (VAS)(Up to 24 hours after the procedure)
  • Changes in heart rate(Up to 24 hours after the procedure)
  • Changes in mean arterial blood pressure(Up to 24 hours after the procedure)
  • Incidence of adverse effects(Up to 24 hours after the procedure)

研究者

发起方
Sameh Fathy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Fathy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

研究点 (1)

Loading locations...

相似试验