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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Programmed intermittent epidural bolus application (PIEB); Procedure: Continous epidural 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).

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35037
    • Philipps Universität Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: Continous epidural analgesia

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Necessity of additional rescue medication	Piritramid 7,5mg	Beginning of operation until 6 pm on the second postoperative day
Sensory blockade	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 )	Beginning of operation -6 pm on the second postoperative day
Patient satisfaction with pain management	Measured on a visual analog scale of 0-10	At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
first defecation/flatus	dichotomous yes/no	after the operation till the end of hospital stay (max 20days)
motor blockade	motor blockade is measured on the Bromage scale 0-3.	Beginning of operation -6 pm on the second postoperative day

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 2, 2017

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: epidural analgesia; PIEB; PCEA
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: nklnk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No