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临床试验/NCT03619447
NCT03619447Unknown4 期

Comparison of the Ultrasound Guided Erector Spinae Plane Block Versus Serratus Plane Block in Totally Mastectomy

Cukurova University0 个研究点目标入组 60 人开始时间: 2018年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
主要终点
morphine consumption

研究概览

简要总结

Total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit to the study. The patients randomly divided into two groups. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

详细描述

In this study, total 60 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent totally mastectomy will recruit. Using with computer randomisation, the patients allocate into two groups. Anaesthesia induction will perform with 2 mg/kg propofol, 0.6 mg/kg rocuronium and 2 microgram/kg fentanil and general anaesthesia will maintain with sevoflurane %1-2 +%40-60 O2-N20 mixture and remifentanil infusion. All of the blocks will perform under general anaesthesia. Ultrasound guided Erector spinae plane block (ESP) will perform with 15 ml bupivacaine+ 5 ml lidocaine in Group ESP and ultrasound guided serratus anterior plane (SAP) block will perform with 5 ml bupivacaine+ 5 ml lidocaine in Group SAP. Postoperative pain, analgesic requirement and complications will evaluate. Postoperative pain assessment will apply with 11-point numerical rating scale (NRS) and postoperative analgesic requirement will calculate and record with morphine consumption (patient controlled analgesia).

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, Care Provider)

盲法说明

Both participants and anaesthesia provider will not know which intervention applied. Another anaesthesia provider who did not perform any block will follow and record to the study data.

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 I-II patients
  • Being volunteer
  • Total mastectomy

排除标准

  • ASA III and over
  • Renal and hepatic failure
  • Non Volunteers
  • Emergency procedures

研究组 & 干预措施

ESP block group

Active Comparator

Under general anaesthesia, Ultrasound guided ESP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.

干预措施: ESP block group (Drug)

serratus block group

Active Comparator

Under general anaesthesia, Ultrasound guided SAP block will perform at the T6 level with15 ml bupivacain+ 5ml lidocaine, bilaterally. Morphine 0.1 mg/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with morphine will apply to the all patients. Postoperative pain assessment and morphine consumption will record till the postoperative 24 th hours.

干预措施: serratus block group (Drug)

结局指标

主要结局

morphine consumption

时间窗: up to postoperative 24th hours.

Patient controlled analgesia (PCA) will provide with morphine PCA. Total morphine consumption will calculate and record till the postoperative 24th hours.

次要结局

  • numerical rating scale score(up to postoperative 24th hours.)

研究者

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

ebru biricik

Anesthesiologist

Cukurova University

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