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临床试验/NCT03803267
NCT03803267已完成不适用

A Comparative Study of Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Open Colorectal Cancer Surgeries

Mansoura University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年5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
入组人数
68
试验地点
1
主要终点
Postoperative pain score

研究概览

简要总结

Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia.

The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and dexamethasone will be used for both techniques.

详细描述

Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the total amount of rescue analgesic consumption and postoperative nausea and vomiting are the parameters of comparison between both techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single blind (participant) study

入排标准

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

入选标准

  • American Society of Anesthesiologists physical status I or II
  • Body mass index from 18.5 to 35 Kg/m2

排除标准

  • Body mass index more than 35 Kg/m
  • Severe or uncompensated cardiovascular disease.
  • Severe renal disease.
  • Severe hepatic disease.
  • Severe endocrinal disease.
  • Pregnancy.
  • Postpartum.
  • Lactating females
  • Allergy to one of the agents used.
  • Refusal to participate in the study.

研究组 & 干预措施

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Erector spinae plane block (Other)

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Propofol (Drug)

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Fentanyl NCS (Drug)

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Atracurium Injectable Product (Drug)

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Endotracheal intubation (Other)

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Anesthesia Maintenance (Drug)

Erector spinae plane block

Active Comparator

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

干预措施: Muscle Relaxation (Drug)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Quadratus lumborum block (Other)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Propofol (Drug)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Fentanyl NCS (Drug)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Atracurium Injectable Product (Drug)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Endotracheal intubation (Other)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Anesthesia Maintenance (Drug)

Quadratus lumborum block

Active Comparator

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

干预措施: Muscle Relaxation (Drug)

结局指标

主要结局

Postoperative pain score

时间窗: From 1 day before the surgery to the 2 days after surgery

The intensity of pain indicated by a segmented numeric scale in which a respondent selects a whole number (0-100 integers) that best reflects his/her pain as 0-30 for mild pain, 30-60 for moderate pain and 60-100 for sever pain

次要结局

  • Systolic Blood Pressure(One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours)
  • Peripheral oxygen saturation(One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours)
  • Time to first rescue analgesic request(Up to 48 postoperative hours)
  • Serum C-reactive protein (CRP)(On hospital admission, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively)
  • Postoperative nausea and vomiting intensity score(Immediately after recovery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours)
  • Heart rate(One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours)
  • Mean Blood Pressure(One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours)
  • Total amount of rescue analgesic consumption(From the time of first analgesic request till the end of the first 24 hours, then till the end of the next 24 hours postoperatively)
  • Cortisol(At 9 Am, 1 hour after induction of general anesthesia, 1st, 24th and 48th hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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