跳至主要内容
临床试验/NCT06412406
NCT06412406已完成不适用

Comparison Between External Oblique Intercostal Plane Block and the Subcostal Transversus Abdominis Plane Block Regarding Intraoperative and Postoperative Analgesia Inpatients Undergoing Paraumbilical Hernia Repair Surgery.

Assiut University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年2月28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
入组人数
62
试验地点
1
主要终点
The effect between external oblique intercostal plane block and the transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain according to numeric rating score (NRS)

研究概览

简要总结

AIM OF STUDY:

Comparison between effect of external oblique intercostal plane block and the subcostal transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain.

详细描述

A paraumbilical hernia is a hole in the connective tissue of the abdominal wall in the midline with close approximation to the umbilicus. If the hole is large enough there can be protrusion of the abdominal contents, including omental fat and/or bowel. These defects are usually congenital and are not noticed until they slowly enlarge over an individual's life time and abdominal contents herniate through the hole creating either pain or a visible lump on the abdominal wall. If abdominal contents get incarcerated (or stuck) in the hole this can cause pain. If the abdominal contents become strangulated by losing their blood supply from pinching or twisting those tissue will die. If it is omental fat this will cause pain and could potentially lead to an infection. If the strangulated contents are bowel then in addition to pain the individual will develop a bowel obstruction. And if the dead bowel is not surgically removed in an emergent fashion the condition could be fatal.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism and respiratory complications and prolongs the hospital stay. This pain is routinely managed using opiates, which are associated with several side effects, including excessive sedation and postoperative nausea and vomiting (PONV) which may increase hospital stay durations. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall.

the subcostal transversus abdominis plane block (TAP) targets the upper abdominal wall.

The EOI block represents an important modification that cover the upper lateral abdominal wall.

subcostal transversus abdominis plane (SCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall,specifically from T6 to L1. The SCTAP has been described that can be performed to provide analgesia for abdominal surgery extending above the umbilicus.

研究设计

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

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

  • •Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
  • •patients with the American Society of Anesthesiologists (ASA) physical status I/II
  • •Patients scheduled for elective paraumbilical hernia

排除标准

  • •1-Known hypersensitivity to the study drugs. 2-Body Mass Index > 40 kg/m
  • •3- Inability to accurately describe postoperative pain to investigators. 4-Opioid tolerance or dependence. 5-Preexisting history of chronic pain. 6-History of renal, liver, cardiac, neuropsychiatric disorder problems. 7-Bleeding or coagulation abnormality. 8-Patients who received any analgesic 24 h before surgery 9-Patients who have difficulty understanding the study protocol

研究组 & 干预措施

External Oblique intercostal (EOI) block

Active Comparator

Group B will include 31 patients to receive EOI block with 20 ml volume on each side ( 0.25% bupivacaine)

干预措施: External Oblique Intercostal (EOI) block (Procedure)

Transversus abdominis plane (TAP) block

Active Comparator

Group A will include 31 patients to receive TAP block with 20 ml volume on each side (0.25 % bupivacaine)

干预措施: Transversus abdominis plane (TAP) block (Procedure)

结局指标

主要结局

The effect between external oblique intercostal plane block and the transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain according to numeric rating score (NRS)

时间窗: baseline

numeric rating scale : from 0 to 10 0 : no pain 1 - 3 : mild pain 4 - 6 : moderate pain 7 - 9 : severe pain 10 : worst pain possible

次要结局

  • Heart rate(baseline)
  • time to start ambulation(baseline)
  • Mean arterial blood pressure(baseline)
  • time of the first opioid request(baseline)

研究者

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

Mohamed Gamal Hassan Rashwan

principal investigator

Assiut University

研究点 (1)

Loading locations...

相似试验