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临床试验/NCT03904082
NCT03904082Unknown不适用

Evaluation of the Efficiency of Erector Spina Plane Block and Serratus Anterior Plane Block for Postoperative Thorasic Pain

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2019年4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
1
主要终点
Verbal analog Pain Scores on rest and movement

研究概览

简要总结

To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.

详细描述

Thoracic wall nerve blocks such as Erector spina Plane block and Serratus Anterior Plane block have become popular for preoperative pain control in patients undergoing thoracotomy.

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)

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

  • •ASA 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

Erector spinae plane block group (ESP)

Active Comparator

Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4 vertebral level will performed preoperatively to patients in the ESP group (Group I).

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

Serratus Anterior Plane Block Group (SAP)

Active Comparator

Single- shot ultrasound (Esaote Mylab30 )guided SAP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) the T4 vertebral level will performed preoperatively to patients in the SAP group( Group II).

干预措施: Serratus Anterior Plane block ( Group ıı) (Procedure)

Control Group

Placebo Comparator

The Control group receive no intervetion ( Group III).

干预措施: Control Group (GROUPIII) (Procedure)

结局指标

主要结局

Verbal analog Pain Scores on rest and movement

时间窗: 48 hours after surgery

A Research assistant, blinded to the group allocation, interviewed patients and collected data at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

opioid consumption

时间窗: 48 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 48 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours).

次要结局

  • Incidences of adverse effects (like nausea and vomitting)(48 hours after surgery)

研究者

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

Ayse Ulgey

Associated professor

TC Erciyes University

研究点 (1)

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