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临床试验/NCT05181371
NCT05181371已完成不适用

Ultrasound Guided, Continuous Erector Spinae Plane (ESP) Block in Minimally Invasive Thoracic Surgery: Comparing Programmed Intermittent Bolus (PIB) vs Continuous Infusion on Quality of Recovery and Postoperative Respiratory Function

Mater Misericordiae University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Quality of Recovery (QoR-15)

研究概览

简要总结

Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient centred outcomes such as quality of recovery.

详细描述

Minimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain, reduce tissue trauma and contribute to better recovery as compared to open thoracotomy. However, it still causes significant acute post-operative pain. Our Mater research group has shown that fascial plane blocks such as the Erector Spinae Plane block (ESP) contribute to post-operative analgesia after MITS. Case reports have described the improved quality of analgesia following ESP using programmed intermittent boluses (PIB) instead of continuous infusion. It is hypothesised that larger, repeated bolus doses provide superior analgesia, possibly as a result of improved spread of the local anaesthetic. Evidence for improved spread of local anaesthetic may be found in one study which demonstrated that PIB increased the number of affected dermatomal levels compared to continuous infusions for continuous paravertebral blocks. Similarly, with regard to labour epidural analgesia, PIB provides better analgesia compared with continuous infusion.

Because fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial plane, automated boluses may be particularly useful for this group of blocks. However, until recently, ambulatory pumps capable of providing automated boluses in addition to patient-controlled boluses were not widely available. To the best of our knowledge, there are no randomised controlled trials comparing continuous infusion versus intermittent bolus strategies for Erector Spinae Plane Block for MITS in terms of patient-centered outcomes such as quality of recovery.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male and Female aged > 18
  • •Able to provide written informed consent
  • •ASA grade I - V
  • •VATS surgery
  • •Weight > 55kg

排除标准

  • •Absence of or inability to give informed consent
  • •Pre-existing infection at block site
  • •Severe coagulopathy
  • •Allergy to local anaesthesia (or another contraindication to block performance)
  • •Previous history of opiate abuse
  • •Pre-existing chronic pain condition
  • •Pre-existing dementia (due to need to co-operate in completing QoR-15 score day after surgery
  • •Postoperative admission to ICU for continued ventilation
  • •BMI > 40 kg/m2

研究组 & 干预措施

Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB)

Active Comparator

After induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive programmed intermittent bolus of local anaesthetic: 20mls 0.125% levobupivacaine every two hours.

干预措施: Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS (Procedure)

Ultrasound Guided ESP Block with Continuous Infusion (CI)

Active Comparator

After induction of general anaesthesia, an ESP catheter will be inserted at the level of T5. A bolus dose of 20 ml 0.25% Levobupicaine will be administered into the ESP space. Two hours post bolus administration, patients will receive a continuous infusion local anaesthetic: 0.125% levobupivacaine at an infusion rate of 10 ml/hr.

干预措施: Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS (Procedure)

结局指标

主要结局

Quality of Recovery (QoR-15)

时间窗: 24 hours

Patient centred metric to measure the quality of recovery after surgery. Scale is between 0-150, where '0' refers to poor quality of recovery and '150' refers to excellent quality of recovery

次要结局

  • Quality of Recovery (QoR-15)(48 hours)
  • Duration of time in PACU .(24 hours)
  • Length of hospital stay(30 days)
  • Time to first mobilisation(48 hours)
  • Maximal inspiratory volume(48 hours)
  • Area Under the Curve for Verbal Rating Score for pain on deep inspiration(48 hours)
  • Area Under the Curve for Verbal Rating Score for pain at rest(48 hours)
  • Time to first intravenous opioid(48 hours)

研究者

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

Aneurin Moorthy

Anaesthesia Specialist Registrar

Mater Misericordiae University Hospital

研究点 (2)

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