PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial (PIEB)
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Programmed intermittent epidural bolus application (PIEB)
Continous epidural analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring PCEA, PIEB, epidural analgesia
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
Sites / Locations
- Philipps Universität Marburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PIEB-PCEA
CEI-PCEA
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
quality of analgesia
Measured on a visual analog scale of 0-10 (0="no pain" ; 10= "worst imaginable pain"
Full Information
NCT ID
NCT03378804
First Posted
October 6, 2017
Last Updated
August 22, 2018
Sponsor
Philipps University Marburg Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03378804
Brief Title
PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial
Acronym
PIEB
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
PCEA, PIEB, epidural analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PIEB-PCEA
Arm Type
Experimental
Arm 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.
Arm Title
CEI-PCEA
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Programmed intermittent epidural bolus application (PIEB)
Intervention Description
Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.
Intervention Type
Procedure
Intervention Name(s)
Continous epidural analgesia
Primary Outcome Measure Information:
Title
Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml)
Description
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
Time Frame
Beginning of operation -6 pm on the second postoperative day
Secondary Outcome Measure Information:
Title
quality of analgesia
Description
Measured on a visual analog scale of 0-10 (0="no pain" ; 10= "worst imaginable pain"
Time Frame
At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
Other Pre-specified Outcome Measures:
Title
Necessity of additional rescue medication
Description
Piritramid 7,5mg
Time Frame
Beginning of operation until 6 pm on the second postoperative day
Title
Sensory blockade
Description
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 )
Time Frame
Beginning of operation -6 pm on the second postoperative day
Title
Patient satisfaction with pain management
Description
Measured on a visual analog scale of 0-10
Time Frame
At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
Title
first defecation/flatus
Description
dichotomous yes/no
Time Frame
after the operation till the end of hospital stay (max 20days)
Title
motor blockade
Description
motor blockade is measured on the Bromage scale 0-3.
Time Frame
Beginning of operation -6 pm on the second postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Philipps Universität Marburg
City
Marburg
ZIP/Postal Code
35037
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30376810
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.
Results Reference
derived
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PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial
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