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临床试验/NCT06599255
NCT06599255Enrolling By Invitation不适用

One-Puncture Versus Multipoint Technique of Rectus Sheath Block With Transverse Abdominis Plane Block for Analgesia After Laparoscopic Cholecystectomy

Zagazig University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
102
试验地点
1
主要终点
The total postoperative opioid consumption in the first 24 hours.

研究概览

简要总结

the purpose of this study is to compare of better postoperative analgesia following laparoscopic cholecystectomy using either one puncture rectus sheath block with transverse abdominis plane block or multipoint technique

详细描述

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3 groups each one containing 34In the One puncture "O" group (n= 34): The patient will receive one-puncture technique of RSB combined with TAPB.

In the Multipoint "M " group (n= 34): The patient will receive multipoint technique of RSB combined with TAPB.

In the Control "C " group (n=34 ): The patient will receive patient controlled analgesia&;PCA&

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, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 18-45 years old.
  • •Sex: both sexes.
  • •Physical status: ASA I to III.
  • •Body mass index (BMI): 18- 30 kg/m
  • •Type of operations: elective laparoscopic cholecystectomy.
  • •Written informed consent from the patient.

排除标准

  • •Known hypersensitivity to lidocaine or bupivacaine.
  • •Opioid-dependent patients.
  • •Coagulation disorders or taking drugs affect surgical hemostasis.
  • •Patients with pre-existing neurological deficits.
  • •Uncooperative patient or with altered mental status.

研究组 & 干预措施

one puncture

Active Comparator

one-puncture technique of RSB combined with TAPB.

干预措施: US-guided RSB and TAPB by one-puncture technique. (Procedure)

Multipoint

Active Comparator

multipoint technique of RSB combined with TAPB.

干预措施: multipont (Procedure)

control

No Intervention

nalbuphine (2 mg/kg) and normal saline to a total volume of 150 mL, with a background infusion rate of 2 mL/h, a bolus dose of 2 mL, a lockout interval of 15 min, and a maximum limit of 10 mL within 1 h.

结局指标

主要结局

The total postoperative opioid consumption in the first 24 hours.

时间窗: 24 hours postoperative

opioid consumption

次要结局

  • The block performance time(up to 5 minutes)
  • Onset of sensory block(up to 30 minutes)
  • The Numerical Pain Rating Scale(24 hours postoperative)
  • Patient satisfaction(24 hour postoperative)

研究者

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

Marwa Mohamed Medhat

assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Zagazig University

研究点 (1)

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