跳至主要内容
临床试验/NCT03267628
NCT03267628撤回不适用

Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections

Dr Willem Basson0 个研究点开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
24 hours total intravenous morphine usage via a PCA pump

研究概览

简要总结

The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.

详细描述

In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.

The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.

In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double blinded

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Anaesthetist trained in QLB and ITM techniques available
  • American Society of Anaesthesiologists PS category client I or II
  • 18 years of age or older
  • Ability to read and understand English
  • Uncomplicated pregnancy at term (>37 weeks completed gestation)
  • Booked elective CS

排除标准

  • Contraindications to spinal anaesthesia
  • History of chronic opioid consumption / chronic pain conditions
  • Known allergy to study drugs
  • Weight more than 95kg or body mass index (BMI) more than 35 pre operative
  • Placenta Previa / accreta
  • Obstructive Sleep apnoea
  • Severe asthma unable to tolerate Non steroidal anti inflammatory agents

研究组 & 干预措施

Saline intrathecal as well as local anaesthetic in Blocks

Active Comparator

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

干预措施: Intrathecal morphine as well as local anaesthetic in Blocks (Procedure)

Saline intrathecal as well as saline in Blocks

Sham Comparator

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

干预措施: Saline intrathecal as well as saline in Blocks (Procedure)

Saline intrathecal as well as saline in Blocks

Sham Comparator

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

干预措施: Saline intrathecal as well as local anaesthetic in Blocks (Procedure)

Saline intrathecal as well as local anaesthetic in Blocks

Active Comparator

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

干预措施: Saline intrathecal as well as saline in Blocks (Procedure)

Intrathecal morphine as well as local anaesthetic in Blocks

Active Comparator

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

干预措施: Intrathecal morphine as well as local anaesthetic in Blocks (Procedure)

Intrathecal morphine as well as local anaesthetic in Blocks

Active Comparator

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

干预措施: Intrathecal morphine as well as saline in Block (Procedure)

Intrathecal morphine as well as saline in Block

Active Comparator

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

干预措施: Intrathecal morphine as well as saline in Block (Procedure)

Intrathecal morphine as well as saline in Block

Active Comparator

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

干预措施: Saline intrathecal as well as local anaesthetic in Blocks (Procedure)

结局指标

主要结局

24 hours total intravenous morphine usage via a PCA pump

时间窗: 24 hours

Post operative intravenous morphine use will be noted at 24 hours post cesarean section

次要结局

  • Patient's side effects within the 24 hours post operative period.(24 hours)
  • Pain Scores within 24 hours post operative period.(24 hours)

研究者

发起方
Dr Willem Basson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Willem Basson

Staff Specialist in Anaesthetics

Sunshine Coast Hospital and Health Service

相似试验