Clinical trial NCT03378804: PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: PCEA
PIEB
epidural analgesia
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml)
timeFrame: Beginning of operation -6 pm on the second postoperative day
Secondary outcomes:
measure: quality of analgesia
timeFrame: At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
Other outcomes:
measure: Necessity of additional rescue medication
timeFrame: Beginning of operation until 6 pm on the second postoperative day
measure: Sensory blockade
timeFrame: Beginning of operation -6 pm on the second postoperative day
measure: Patient satisfaction with pain management
timeFrame: At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
measure: first defecation/flatus
timeFrame: after the operation till the end of hospital stay (max 20days)
measure: motor blockade
timeFrame: Beginning of operation -6 pm on the second postoperative day
Locations:
city: Marburg
country: Germany
facility: Philipps Universität Marburg
Study officials:
References:
citation: Wiesmann T, Hoff L, Prien L, Torossian A, Eberhart L, Wulf H, Feldmann C. Programmed intermittent epidural bolus versus continuous epidural infusion for postoperative analgesia after major abdominal and gynecological cancer surgery: a randomized, triple-blinded clinical trial. BMC Anesthesiol. 2018 Oct 30;18(1):154. doi: 10.1186/s12871-018-0613-6.