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临床试验/NCT04003909
NCT04003909已完成不适用

Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Bassant M. Abdelhamid1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年7月5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
发起方
入组人数
30
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.

详细描述

This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study.

All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group:

Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia.

Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block .

Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.

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
Single (Outcomes Assessor)

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

  • •Patients aged from 40 to 65 years old
  • •Both sexes.
  • •ASA I-II.
  • •Undergo hip replacement surgery.
  • •Body mass index (BMI) from 18 to 35 kg/m2.

排除标准

  • •Patient refusal.
  • •Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
  • •Known allergy to local anesthetics.
  • •ASA III-IV.
  • •Patients with difficulty in evaluating their level of pain.

研究组 & 干预措施

ESP group

Experimental

patients will have ultrasound guided ESP block before spinal anesthesia.

干预措施: ultrasound-guided Erector spinae plane block (Procedure)

ESP group

Experimental

patients will have ultrasound guided ESP block before spinal anesthesia.

干预措施: subarachonoid block (Procedure)

Control group

Experimental

patients will have spinal Anesthesia without ESP block

干预措施: subarachonoid block (Procedure)

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperative

Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively.

次要结局

  • Visual analogue scale(30 minutes,2,4, 6, 12, and 24 hours postoperative.)
  • Duration of analgesia(24 hours postoperative)
  • Incidence of complications(24 hours)

研究者

发起方
Bassant M. Abdelhamid
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bassant M. Abdelhamid

associate professor

Cairo University

研究点 (1)

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