跳至主要内容
临床试验/NCT03769818
NCT03769818已完成不适用

Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 150 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
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Visual analog score for pain during movement

研究概览

简要总结

The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

  • Group 2: bupivacaine 0.25%
  • Group3: control group A prospective Randomized Interventional double-blind study.

详细描述

Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete for group 1 and 2.

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy

排除标准

  • Participants had known sensitivity to bupivacaine
  • Participants had difficulty in intubation
  • Participants were on chronic pain medication or already on long-term opioids
  • Participants smokers
  • Participants with disabilities who were unable to communicate pain levels
  • refuse to consent

研究组 & 干预措施

bupivacaine and dexamethasone

Active Comparator

Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

干预措施: bupivacaine (Drug)

bupivacaine and dexamethasone

Active Comparator

Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

干预措施: dexamethasone (Drug)

bupivacaine and placebo to dexamethasone

Active Comparator

Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

干预措施: bupivacaine (Drug)

bupivacaine and placebo to dexamethasone

Active Comparator

Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

干预措施: placebo to dexamethasone (Drug)

control group

Placebo Comparator

Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone

干预措施: placebo to dexamethasone (Drug)

control group

Placebo Comparator

Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone

干预措施: placebo to bupivacaine (Drug)

结局指标

主要结局

Visual analog score for pain during movement

时间窗: 24 hours post operative

movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

次要结局

  • number of days patients stay in hospital(4 weeks)
  • Visual analog score for pain during rest(24 hours postoperative)
  • number of patients need Fentanyl consumption(24 hours postoperative)

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hany farouk

Principal Investigator

Aswan University Hospital

研究点 (1)

Loading locations...

相似试验

Role of Dexamethasone for Erector Spinae Plane Block... | 临床试验