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临床试验/NCT03555227
NCT03555227已完成不适用

Ultrasound Guided (USG) PECS Versus Local Infiltration Anaesthesia (LIA) for Breast Cancer Surgery - A Randomized Quadruple Blinded Efficacy and Safety Study

National Health Service, United Kingdom2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Morphine consumption in Recovery

研究概览

简要总结

Breast cancer is the most common cancer for which women in the UK (United Kingdom) undergo surgery. A novel ultrasound guided regional anaesthetic technique called the 'Pecs 2' block has recently been described. This study compares ultrasound guided (USG) Pecs 2 block with local anaesthetic infiltration (LIA) for pain relief following breast cancer surgery.

详细描述

Breast cancer is the commonest cancer in UK for which women undergo surgery. Pain relief for breast surgery may be either opioid/morphine based or regional or local anesthetic technique based. Both have specific advantages and disadvantages. Regional anesthesia is known to suppress the stress response to surgery by blocking noxious afferent neural input into the central nervous system. Locoregional anesthetic techniques offer excellent pain relief without the disadvantages of morphine.These include thoracic epidural anesthesia, paravertebral block, intercostal blocks and local anesthetic infiltration of the wound. More recently, a novel ultrasound guided interfascial nerve block technique the 'Pecs block' was proposed by Blanco et al which provides an alternative method of providing postoperative analgesia for breast surgery.There is also evidence, albeit limited to support use of local anesthetic infiltration in breast surgery, which is widely used for analgesia.

Currently, there are no large randomised control trials to prove the safety and efficacy of ultrasound guided Pecs blocks in breast surgery. Also, wound infiltration with local anesthetic is practiced widely and to date, there has been no study comparing local anesthetic wound infiltration with USG pecs blocks.

On this background, we intend to perform a prospective randomised double blinded trial to evaluate the efficacy and safety of ultrasound guided Pecs blocks for breast surgery by comparing it local anesthetic wound infiltration.

This is a single-centre, prospective, double blinded randomised case control interventional study. The study plans to enroll 110 participants.

Patients will be randomly allocated to either group X or Y using computer generated numbers. Standard monitoring as per AAGBI (Association of anesthetists of Great Britain and Ireland) guidelines will be instituted as per clinical requirement. All patients will be anaesthetized using total intravenous anesthesia using TCI (target controlled infusions) of propofol and remifentanil. Intraoperatively, propofol and remifentanil infusions shall be titrated by the anesthetist to maintain adequate depth of anesthesia and 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

All patients will be receiving both interventions i.e. USG PECS blocks and wound infiltration anesthesia, with local anesthetic 0.25% levobupivacaine (active) and 0.9% Saline depending on the randomized group allocations. As such patients will be blinded.The anaesthetist and surgeon doing the interventions will both be blinded as to the pharmacological contents of the drug. This will be done as mentioned with pharmacy labelling the drugs as "PRE" used for USG pecs block and "POST" for wound infiltration. Also the observer, in this case the recovery nurse who will be titrating analgesia in the immediate postoperative period shall be blinded as to what group the patient belongs to.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female breast cancer patients
  • Admitted to Craigavon Area Hospital
  • Requiring and undergoing elective/urgent unilateral breast surgery as set out in the protocol

排除标准

  • Patient allergic to local anaesthetic
  • Any condition precluding safe use of USG pecs blocks e.g. Infection at site, anatomical abnormality etc.
  • Preoperative chronic pain and or on pain medication over and above simple analgesics. Patients receiving any analgesia other than paracetamol, NSAIDS and codeine shall be excluded from the study.
  • Bilateral breast surgery
  • Consent declined

结局指标

主要结局

Morphine consumption in Recovery

时间窗: 24 hours

A measure of total amount in milligrams of morphine required in recovery

Numeric Rating Scale (NRS) Pain scores

时间窗: 24 hours

Self reported pain scores between 0-10 (0- no pain; 10- severe pain, as bad as can be) in recovery

次要结局

  • S -LANNS (Self- administered Leeds Assessment of Neuropathic Symptoms and Signs) questionnaire for chronic post surgical pain(1 year)
  • Cancer recurrence or metastasis(1 year)
  • PONV (Post operative nausea and vomiting) Impact Scale Score(2 hours)

研究者

发起方
National Health Service, United Kingdom
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shiva ARAVA

Doctor, Consultant Anaesthetist

National Health Service, United Kingdom

研究点 (2)

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