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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Programmed intermittent epidural bolus application (PIEB)
* Procedure: Continous epidural analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIEB-PCEA<br>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. | Procedure: Programmed intermittent epidural bolus application (PIEB)<br>* Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.<br>|
| Active Comparator: CEI-PCEA<br>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. | Procedure: Continous epidural analgesia<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml) | 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 | Beginning of operation -6 pm on the second postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of analgesia | Measured on a visual analog scale of 0-10 (0=no pain ; 10= worst imaginable pain | At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCEA, PIEB, epidural analgesia