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临床试验/NCT06092073
NCT06092073已完成不适用

Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月21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
入组人数
40
试验地点
1
主要终点
Time to the 1st rescue analgesia

研究概览

简要总结

The aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (RIFPB) in epigastric hernia.

详细描述

Epigastric hernias are usually occult in obese patients, and their symptoms may mimic peptic ulcer or gallbladder disease . Hernia repair is associated with considerable postoperative pain.

The recto-intercostal fascial plane block (RIFPB) is a new novel approach that was developed by Tulgar et al., 2023 who hypothesized that when we inject a local anesthetic into the interfacial plane just inferolateral to the xiphoid, between the rectus abdominis muscle and the 6-7th costal cartilages (hence, between the cartilages and the intercostal muscles between them), blockade of the anterior branches of the nerves passing through this area can be guaranteed.

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
None

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 18-65 years.
  • •Both sexes.
  • •American Society of Anesthesiology (ASA) physical status I-II.
  • •Scheduled for elective epigastric hernia repair.

排除标准

  • •Obese patients with body mass index (BMI) >35 kg/m
  • •Patients with a large hernia containing bowel.
  • •Patients with local anesthetic allergy.

研究组 & 干预措施

RIFPB group

Experimental

Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.

干预措施: recto-intercostal fascial plane block (Procedure)

Control group

No Intervention

Patients will not receive the block.

RIFPB group

Experimental

Patients will receive bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 mL of bupivacaine 0.25% on each side.

干预措施: bupivacaine (Drug)

结局指标

主要结局

Time to the 1st rescue analgesia

时间窗: 24 hours postoperatively

Rescue analgesia in the form of 3 mg of IV morphine will be given if the numeric rating scale (NRS) score \> 3. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

次要结局

  • Intraoperative mean arterial pressure(Till the end of surgery.)
  • Intraoperative fentanyl consumption(Intraoperatively.)
  • Total morphine consumption in the 1st 24hr(24 hours postoperatively)
  • Pain score(24 hours postoperatively)
  • Intraoperative heart rate(Till the end of surgery.)
  • Complications(24 hours postoperatively)

研究者

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

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (1)

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