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Completed

NCT Number: NCT03378804

PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps Universität Marburg

Marburg, 35037, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Programmed intermittent epidural bolus application (PIEB)

Procedure

Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.

Continous epidural analgesia

Procedure

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. quality of analgesia

    Time frame: At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day

    Measured on a visual analog scale of 0-10 (0="no pain" ; 10= "worst imaginable pain"

Other outcomes

  1. Necessity of additional rescue medication

    Time frame: Beginning of operation until 6 pm on the second postoperative day

    Piritramid 7,5mg

  2. Sensory blockade

    Time frame: Beginning of operation -6 pm on the second postoperative day

    Sensory blockade is measured with a tiptherm, motor blockade on the Bromage scale 0-3 (0= no blockade; 1=Inability to lift legs stretched; 2=Inability to bend knees, 3=Inability to move feet )

  3. Patient satisfaction with pain management

    Time frame: At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day

    Measured on a visual analog scale of 0-10

  4. first defecation/flatus

    Time frame: after the operation till the end of hospital stay (max 20days)

    dichotomous yes/no

  5. motor blockade

    Time frame: Beginning of operation -6 pm on the second postoperative day

    motor blockade is measured on the Bromage scale 0-3.

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

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

Acronym: PIEB

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2017
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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