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临床试验/NCT03551860
NCT03551860Unknown不适用

A Comparative Evaluation of Quadratus Lumborum Block Versus Fascia Iliaca Nerve Block for Patients Undergoing Elective Total Hip Replacement Under Spinal Anaesthesia

The Adelaide and Meath Hospital, incorporating The National Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
24 hour morphine consumption between the two groups

研究概览

简要总结

Investigators hypothesise that for patients undergoing elective total hip replacements, a single injection Transmuscular Quadratus Lumborum (TQL) block, when compared to a single injection Fascia Iliaca Block (FIB), will provide better analgesia and less motor block in the initial 24 hour period.

详细描述

Total hip replacement is a commonly performed surgical procedure with up to 4,500 procedures performed annually in Ireland and up to 400,000 per year in the United States. Most of the patients experience moderate to severe pain in the initial post-operative period. Multimodal analgesia with peripheral nerve blockade is recommended as the gold standard modality for management of lower limb joint replacements. The limitations with peripheral nerve block include duration of therapy with single shot injections and associated motor block which can delay rehabilitation.

Transmuscular Quadratus Lumborum injection has been described recently as an effective option for post-operative analgesia in patients undergoing total hip replacement. Single injection can provide analgesia for up to 24 hours. We aim to investigate if a TQL block when compared to FIB provides superior analgesia and less motor block in the acute post-operative period.

All patients scheduled for elective hip replacement surgery will be contacted prior to the surgery (at least 24 hours) over the telephone and information about the nature and purpose of the study will be provided to them by Anaesthesia personnel who are involved in the study. They will be directed to a dedicated page on our website to further inform themselves, if desired. Written informed consent will be obtained from all patients prior to participation in the study. Patients can remove their consent without question at any time during or after the study.

Patients will be randomised to either the TQL group (intervention group) or FIB group (conventional group) by computer generated random numbers and allocation will be enclosed in sealed envelopes. Due to the nature of the intervention, the Anaesthetist performing/supervising the block and patient receiving the block cannot be blinded. Outcome measurements will be recorded by study observers blinded to the group allocation.

On arrival to the Anaesthesia induction room baseline monitoring (non-invasive blood pressure, pulse oximetry and 3-lead ECG) and intravenous access will be established. Patients in both groups will be positioned sitting on a level trolley with feet resting on a foot rest. They will be given a pillow to hug and requested to maintain an arched back posture with an assistant holding the patient to aid positioning. No sedation will be given prior to or during administration of spinal anesthesia.

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 (Investigator, Outcomes Assessor)

盲法说明

Due to nature of intervention (one single injection vs a second single injection in different anatomical location) the participant and the care provider cannot be blinded.The investigator will use an already filled data collection sheet and enter randomised data into a master file. The data will be analysed by an individual blinded to the which group the participant was in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective total hip replacements under spinal anaesthesia
  • Age > 18 yrs.
  • Patient is able to provide written informed consent

排除标准

  • Local infection
  • Allergy to local anaesthetics
  • Severe coagulopathy

研究组 & 干预措施

TQL Group

Experimental

Administration of a single shot transmuscular quadratus lumborum (TQL) peripheral nerve block following spinal neuraxial blockade.

干预措施: TQL (Procedure)

FIB Group

Active Comparator

Administration of a single shot fascia iliac (FIB) peripheral nerve block following spinal neuraxial blockade.

干预措施: FIB (Procedure)

结局指标

主要结局

24 hour morphine consumption between the two groups

时间窗: 24 hour post-operative period

Intravenous Patient Controlled Analgesia (PCA) Morphine will be set up and explained to all participants. The AMNCH hospital standard will be use. This is 2mg/ml concentration; 1mg dose; 6 minute lockout period between administration; maximum morphine consumption of 40mg within a 4 hour period.

次要结局

  • Motor Block(24 hours post-operative period - measured at 6 and 24 hours)
  • Numerical Rating Scale (NRS) for Pain(24 hours post-operative period - measured at 6 and 24 hours)

研究者

发起方
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karthikeyan Kallidaikurichi Srinivasan

Consultant Anaesthetist

The Adelaide and Meath Hospital, incorporating The National Children's Hospital

研究点 (1)

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