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临床试验/NCT02210260
NCT02210260已完成不适用

Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial

York Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
1
主要终点
Neuroendocrine response to surgery

研究概览

简要总结

Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols.

Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response.

We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery.

We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.

详细描述

This is a pilot randomised controlled trial

Hypotheses -

Following colorectal surgery, spinal anaesthesia combined with a continuous infusion of local anaesthetic into the surgical wound provides

  1. better pain relief
  2. a reduced stress response

when compared to the use of continuous infusion of local anaesthetic into the surgical wound alone.

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 (Participant, 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

  • All patients who are undergoing either laparoscopic or open colorectal resections will be considered eligible for the study.

排除标准

  • Patients under 18 years of age.
  • Pregnant females.
  • Patients undergoing an abdominoperineal resection.
  • Patients who will not contemplate being randomized to receive a spinal anaesthetic.
  • Patients with a history of failure to place an epidural / spinal anaesthetic.
  • Hypersensitivity to local anaesthetics.
  • Lack of capacity to give consent.

研究组 & 干预措施

Continuous infusion of local anaesthetic

Active Comparator

Continuous infusion of local anaesthetic into the surgical wound

干预措施: Continuous infusion of local anaesthetic (Procedure)

Continuous infusion of local anaesthetic

Active Comparator

Continuous infusion of local anaesthetic into the surgical wound

干预措施: Bupivacaine (Drug)

Continuous infusion of local anaesthetic

Active Comparator

Continuous infusion of local anaesthetic into the surgical wound

干预措施: A Painbuster® catheter (Device)

Spinal and infusion of local anaesthetic

Experimental

A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound

干预措施: Spinal and infusion of local anaesthetic (Procedure)

Spinal and infusion of local anaesthetic

Experimental

A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound

干预措施: Bupivacaine (Drug)

Spinal and infusion of local anaesthetic

Experimental

A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound

干预措施: Diamorphine (Drug)

Spinal and infusion of local anaesthetic

Experimental

A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound

干预措施: A Painbuster® catheter (Device)

Spinal and infusion of local anaesthetic

Experimental

A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound

干预措施: 25G Whitacre needle (Device)

结局指标

主要结局

Neuroendocrine response to surgery

时间窗: 24 hours

Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for cortisol and noradrenaline.

次要结局

  • Oxidative stress(For 24 hours)
  • Amount of postoperative IV fluid administered(Up to 12 days)
  • Length of hospital stay or fitness for discharge(Up to 12 days)
  • Postoperative analgesic requirement(Up to 72 hours after surgery)
  • Episodes of hypotension in the postoperative period(Up to 12 days)
  • Postoperative complications(Up to 12 days)
  • Postoperative pain(Up to 72 hours after surgery)
  • Postoperative mobility(Up to 12 days)
  • Return of gut function(Up to 12 days)
  • Inflammatory pathway(Up to 24 hours after surgery)

研究者

发起方
York Teaching Hospitals NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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