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

Philipps University

Status: Completed

Conditions: Pain, Postoperative

Treatments: Procedure: Programmed intermittent epidural bolus application (PIEB); Procedure: Continous epidural analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03378804

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Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

PIEB-PCEA

Experimental group

Description:

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.

Treatment:

Procedure: Programmed intermittent epidural bolus application (PIEB)

CEI-PCEA

Active Comparator group

Description:

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.

Treatment:

Procedure: Continous epidural analgesia