Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery
1 other identifier
interventional
88
1 country
1
Brief Summary
Epidural analgesia is an efficient way to relieve pain after major abdominal surgery. Two different protocols are used to provide analgesia: continuous epidural infusion (CEI) and programmed intermittent boluses (PIEB). CEI consists in the delivery of a continuous administration of the intended hourly dose. PIEB consists in the administration of sequential high pressure boluses of the intended dose. Although some studies in the postoperative setting have observed that PIEB reduces the total dose needed to ensure adequate pain control, the clinical value of this finding is still uncertain. Moreover, nursing and medical interventions to the epidural infusion rates are frequently needed in the first 48 postoperative hours to optimize the provision of analgesia. These interventions add to the already important nursing workload associated with major abdominal surgery, and are correlated with suboptimal analgesia for the patient. This randomized controlled trial aims to compare the effect of epidural PIEB on the workload as a reflection of adequate analgesia compared to the standard CEI protocol in use. The investigators hypothesize that the use of PIEB decreases the number of interventions needed to obtain adequate analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 20, 2021
January 1, 2021
6 months
January 22, 2020
January 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of epidural infusion adjustments
Number of epidural infusion adjustments by the nursing team (based on the usual protocol of our institution) will be recorded.
48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Outcomes (13)
Quality of analgesia
48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Additional analgesia
48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Incidence of hypotension
48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Vasopressor use
48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Total epidural dose of local anesthetic administered
48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
- +8 more secondary outcomes
Study Arms (2)
Programmed intermittent epidural bolus (PIEB)
EXPERIMENTALProgrammed intermittent epidural boluses of bupivacaine 0,1% are administered every hour.
Continuous epidural infusion (CEI)
EXPERIMENTALA continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate in milliliters per hour.
Interventions
Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia. Standardized patient-controlled epidural boluses are available as top-ups.
A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia. Standardized patient-controlled epidural boluses are available as top-ups.
A morphine infusion (0,1mg/ml) is administered in both groups at a prescribed rate. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia.
Eligibility Criteria
You may qualify if:
- Adult patients (18 years and older)
- Major abdominal surgery in an elective setting
- Thoracic epidural (between T7 and T12)
You may not qualify if:
- Contraindication to bupivacaine
- Contraindication to morphine
- Decision to keep the patient intubated and sedated at the end of the surgery
- Chronic opioid use (\> 3 months)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Quebec-Universite Laval
Québec, G1R 2J6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esther Breton, MD, FRCPC
CHU de Québec-Universite Laval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single (participant)
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor Esther Breton, MD, FRCPC
Study Record Dates
First Submitted
January 22, 2020
First Posted
February 5, 2020
Study Start
November 14, 2019
Primary Completion
May 23, 2020
Study Completion
December 1, 2020
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share