跳至主要内容
临床试验/NCT01621698
NCT01621698已完成不适用

Early Versus Late Paravertebral Block for Analgesia in Video Assisted Thoracoscopic Lung Resection.

University Hospitals Bristol and Weston NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Pain score on coughing using Visual Analogue Scale (VAS).

研究概览

简要总结

This project involves looking at the timing of providing pain relief for patients who are having lung surgery via the use of a small camera inserted into the chest with a scope (Video assisted thorascopy). This procedure can be the source of intense pain both immediately after the procedure and in the longer term leading to chronic pain problems.

Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal column, where the pain nerve fibres are located, is a well recognized method of providing pain relief for these procedures. It is currently unclear as to the best timings for providing this type of pain relief with some centres placing the local anaesthetic at the start of the procedure and some at the end. Placing a high volume of local anaesthetic into this area at the start of the case may provide better short and long term pain relief than placing it at the end of the procedure. The investigators hope to show a difference between the two timings to allow for better pain relief for these procedures. This would be a feasibility study that would lead onto a multicentre trial to eventually create a best practice protocol for pain relief for lung resection via this surgical method.

详细描述

All patients will receive a general anaesthetic for their VATS procedure with full AAGBI monitoring and the WHO surgical safety checklist will be performed appropriately prior to skin incision. Induction of anaesthesia will be standardised by using propofol and the patient will be paralysed using the muscle relaxant atracurium. The amount given will be at the anaesthetist's discretion and dependent on the patient. Fentanyl at 2.5 mcg/kg will be used at induction of anaesthesia.

A double lumen endotracheal tube will be placed so lung isolation can be performed when necessary for the surgery. Anaesthesia will be maintained using a volatile agent or a target controlled infusion of propofol depending on the preference of the anaesthetist. The patient will be positioned laterally with the operative side up. All patients will receive simple intra-operative analgesia in the form of 1 gram of intravenous paracetamol and diclofenac unless the patient is over 70 or has abnormal renal function. Extra opioid analgesia will be given as intravenous morphine and this will be titrated by the anaesthetist. The amount given will be documented as part of the trial data.

Patients will be warmed to maintain a temperature between 36 and 37 degree Celsius using a warming blanket and warmed intravenous fluids. Anti-emetics in the form of ondansetron 4 mg and dexamethasone 4 mg will also be given unless there are any contraindications.

Prior to surgical incision patients in both groups will receive 1mg/kg 0.25% bupivicaine divided into 3 PV injections between the fifth and tenth thoracic vertebrae. Only trained anaesthetists with experience of over 30 PV insertions will perform the injections. The landmark technique for these injections is as follows: The spinous process of the thoracic vertebra is palpated by the anaesthetist, a 20 gauge needle is inserted 2.5 cm lateral to this and is advanced perpendicularly to the vertical and sagittal planes until the transverse process is contacted. The needle is then walked off the superior border of the transverse process, advanced a further 1 cm and one third of the weight determined local anaesthetic is delivered after careful aspiration.

Both groups will have a PV catheter placed at the start of the procedure and a bolus given straight away. As this is a double-blinded trial the anaesthetist will not know whether the bolus is local anaesthetic or saline solution.

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, Care Provider, Investigator)

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

  • Subjects will be recruited from patients admitted for elective VATS for lung resection.
  • Patients aged 18 and over.
  • Patient's will be ASA 1,2 or 3.

排除标准

  • Patient refusal.
  • Emergency surgery.
  • Patient unable to provide consent.
  • Infection in paravertebral space.
  • Patients who attend a chronic pain clinic on high doses of opiate drugs.
  • History of Anaphylaxis/allergy to local anaesthetic.

结局指标

主要结局

Pain score on coughing using Visual Analogue Scale (VAS).

时间窗: 24 hours.

Pain scores in first 24 hours to be analysed using area under the curve.

次要结局

  • Morphine consumption(24 hours)
  • Cortisol levels(24 hours)
  • Length of hospital stay(3 days (Average))
  • Readmission rates(30 days)
  • Survival(30 days)
  • Patient satisfaction scores(24-48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验