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临床试验/NCT03378804
NCT03378804已完成不适用

Randomized Comparison of Two Application Procedures: Programmed Intermittent Epidural Bolus in Patient-controlled Epidural Analgesia (PCEA) Versus Continous PCEA in Abdominal Oncological Surgery

Philipps University Marburg Medical Center2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年1月最近更新:
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
110
试验地点
2
主要终点
Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml)

研究概览

简要总结

The aim of the study is to compare programmed intermittent bolus application and continuous epidural infusion with regard to additionally applied patient-controlled volume of local anesthesia and quality of analgesia.

详细描述

Usually, patient controlled epidural analgesia (PCEA) is performed with a constant background infusion and patient-controlled bolus applications. An alternative approach is to give boluses at a regular rate for basic medication, instead of the continuous background infusion, maintaining the same amount of medication delivered per hour, (Programmed Intermittent Epidural Bolus injection; PIEB). In both cases, the patient has the option to trigger additional boluses. PIEB has been applied successfully in pain relief for lumbar epidural anesthesia in obstetrics, with better quality of analgesia and less total volume of local anesthetic required. It is assumed that the higher pressure in the epidural space with bolus injection results in a better and more uniform spread of the local anesthetic. In this study the PIEB-mode will be applied in major gynecological and abdominal surgery. In order to address the possibility that the different types of surgery result in different degrees of postoperative pain, the patients are stratified in three groups and randomized within these groups (Wertheim, Whipple, major colon surgery).

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)

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

  • Abdominal tumors in gynecology and general surgery
  • Enlightenment and written consent to the investigation

排除标准

  • refusal to participate
  • pregnancy and breast feeding period
  • general contraindications for thoracic epidural anesthesia (e.g. coagulation disorders, --anticoagulation according to the guidelines of DGAI)
  • Impossibility to place the epidural catheter correctly
  • Known allergy to the drugs used in the study
  • Lack of understanding how to use the patient-controlled system
  • postoperative follow-up respiratory assistance

研究组 & 干预措施

PIEB-PCEA

Experimental

Programmed intermittent epidural bolus (PIEB) application of ropivacaine 0.2% with patient-controlled epidural analgesia:

The background rate is set at 6ml per hour. The patient-controlled bolus function is programmed with 4ml at a lock-out interval of 30min.

干预措施: Programmed intermittent epidural bolus application (PIEB) (Procedure)

CEI-PCEA

Active Comparator

Continous epidural analgesia with patient-controlled analgesia using ropivacaine 0.2%:

The background rate is set at 6 ml / h continuously. The patient-controlled bolus function is programmed in with 4ml at a lock-out interval of 30min.

干预措施: Continous epidural analgesia (Procedure)

结局指标

主要结局

Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml)

时间窗: Beginning of operation -6 pm on the second postoperative day

The patient-controlled bolus function is programmed with 4ml at a lock-out interval of 30min. The number of additional patient-controlled boli will be read off the epidural pump at 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day

次要结局

  • quality of analgesia(At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day)

研究者

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

Lara Maria Prien

Research Associate

Philipps University Marburg Medical Center

研究点 (2)

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