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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-11-02

Brief Summary

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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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Detailed Description

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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).

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PIEB-PCEA

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.

Group Type EXPERIMENTAL

Programmed intermittent epidural bolus application (PIEB)

Intervention Type PROCEDURE

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

CEI-PCEA

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.

Group Type ACTIVE_COMPARATOR

Continous epidural analgesia

Intervention Type PROCEDURE

Interventions

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Programmed intermittent epidural bolus application (PIEB)

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

Intervention Type PROCEDURE

Continous epidural analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No