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临床试验/NCT03904095
NCT03904095Unknown不适用

Comparison Between the Analgesic Efficacy of Erector Spinae Plane Block and Psoas Compartment Block in Hip Surgery

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
105
试验地点
2
主要终点
opioid consumption

研究概览

简要总结

To evaluate the ability of Erector spina Plane block and Psoas compartment block to decrease postoperative pain and analgesia requirements in patients undergoing hip surgery.

详细描述

Erector spina Plane block or Psoas compartment block will performed with guided ultrasound at L4 Transverse process level would lead to adequate postoperative analgesia ,in total hip arthroplasty surgeries.

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, Investigator)

盲法说明

participant care provider

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

入选标准

  • ASA (American Society of Anesthesiologists) I- ASA II Patients

排除标准

  • history of allergy to the study medication
  • refusal to participate

研究组 & 干预措施

Psoas compartment block group (PCB)

Active Comparator

Single- shot ultrasound (Esaote Mylab30) guided PCB with 15 ml 0.25% bupivacain ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the PCB group (Group I).

干预措施: Psoas Compartment Block Group (GROUP I) (Procedure)

Erector spinae plane block group (ESP)

Active Comparator

Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% ( Marcain 0.5%, Astra zeneca, Turkey) at the L4 vertebral level will performed preoperatively to patients in the ESP group (Group II).

干预措施: Erector Spinae Plane block ( Group II) (Procedure)

The Control group

Placebo Comparator

The Control group receive no intervention ( Group III).

干预措施: Control Group (GROUP III) (Procedure)

结局指标

主要结局

opioid consumption

时间窗: 24 hours after surgery

In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

Verbal analog Pain Scores on rest and movement

时间窗: 24 hours after surgery

A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

次要结局

  • incidences of adverse effects (like nausea and vomiting)(24 hours after surgery)

研究者

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

Sibel Seçkin Pehlivan

Teaching Assistant

TC Erciyes University

研究点 (2)

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