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临床试验/NCT03778671
NCT03778671已完成1 期

Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block in Elderly Patients Undergoing Lower Abdominal Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
first analgesic request

研究概览

简要总结

The perioperative management of pain following lower abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

详细描述

One method used in this multimodal approach is the transversus abdominis plane block. This block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal wall. In 2007, McDonnell et al. further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid mediated side effects. In this same year, Hebbard et al. described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve transversus abdominis plane block accuracy. In 2008, Hebbard. described the subcostal approach of transversus abdominis plane block, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of transverses abdominis plane block duration is limited to effect of administered local anesthetics.The use of an infusion catheter to administer local anesthetics is an option to prolong the block's duration. Recently, adjuvant medications were added to local anesthetics to prolong the effect of transverses abdominis plane block .

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status II-III,
  • scheduled for uncomplicated elective paraumbilical hernia repair.

排除标准

  • Patient refusal to participate in the study
  • Patients with coagulopathy or under anticoagulation therapy.
  • Infection near the site of needle insertion.
  • Body mass index > 40kg/m2
  • Patients with any neurological or neuromuscular disorder or history of seizures.

研究组 & 干预措施

Group B

Experimental

Patients will receive Levobupivacaine 5%

干预措施: Levobupivacaine (Drug)

Group D

Active Comparator

Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .

干预措施: Dexmedetomidine Injection [Precedex] (Drug)

Group F

Active Comparator

Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl

干预措施: fentanyl (Drug)

结局指标

主要结局

first analgesic request

时间窗: 24 hours

first time to call for analgesia

次要结局

未报告次要终点

研究者

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

Ghada Mohammed AboelFadl

principal investigator

Assiut University

研究点 (1)

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