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临床试验/CTRI/2019/08/020751
CTRI/2019/08/020751已完成不适用

Comparative evaluation of continuous infusion versus intermittent bolus technique in ultrasound guided Erector Spinae Block in breast cancer patients undergoing modified radical mastectomy surgery- A randomized controlled trial

AIIMS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月19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
AIIMS
入组人数
50
试验地点
1
主要终点
Postoperative opioid consumption after Erector Spinae block.

研究概览

简要总结

Breast surgery is an exceedingly common procedure and associated with an increased incidence of acute and chronic post surgical pain. Systemic opiods used in analgesia have the disadvantages of nausea, vomiting, respiratory depression and immune depression risking cancer patients to the risk of recurrence. Regional anaesthesia techniques may improve the postoperative analgesia for patients undergoing breast surgery and may even prevent the development of persistent post-surgical pain. Erector Spinae plane block is a recently discovered technique which provides better postoperative analgesia and the technique also lends itself to insertion of an indwelling catheter which can be used to extend the duration of analgesia as needed. After placing the catheter, local anaesthetic will be administered either as continuous infusion or intermittent boluses. However, there is limited literature to support the advantage of one technique over the other. This study hypothesizes that there will be less opioid consumption with intermittent bolus technique compared to continuous infusion technique as intermittent bolus technique is a volume dependent block and there will be wider coverage of required dermatome for analgesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Patients with breast cancer scheduled for unilateral modified radical mastectomy.
  • •ASA I-II patients.
  • •Patient consenting for study.

排除标准

  • •Patients refusing to participate.
  • •Patients with history of coagulopathy.
  • •Patients on anticoagulant therapy with deranged INR or aPTT values.
  • •Patients with history of known allergy to local anaesthetics and other induction agent drugs.
  • •Patients with local site infection.
  • •Patients with BMI >35 kg/m2.

结局指标

主要结局

Postoperative opioid consumption after Erector Spinae block.

时间窗: At 24hours

次要结局

  • Patient satisfaction(24 hours)
  • Time to first bolus of rescue analgesic by PCA pump.(at time of request of rescue analgesic by patient)
  • Numeric Pain Rating Scale score(0,1,2,4,6,12,24 hours)
  • Dermatomal sensory mapping(at 30 minutes and 24 hours after block (by 3 point -scale).)
  • Intraoperative fentanyl consumption.
  • Incidence of Postoperative nausea and vomiting.
  • Assessment of Quality of recovery by QOR-15 questionnaire
  • Catheter related complications(24 hours)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

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