Clinical trial NCT04254523: Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery
Official title: Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Major Abdominal Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Epidural
Pain, Postoperative
Keywords: Anesthesia, Epidural
Postoperative Period
Analgesia, Patient-Controlled
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years and older)
* Major abdominal surgery in an elective setting
* Thoracic epidural (between T7 and T12)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of epidural infusion adjustments
timeFrame: 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:
measure: Quality of analgesia
timeFrame: 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)
measure: Additional analgesia
timeFrame: 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)
measure: Incidence of hypotension
timeFrame: 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)
measure: Vasopressor use
timeFrame: 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)
measure: Total epidural dose of local anesthetic administered
timeFrame: 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)
measure: Total epidural dose of opioid administered
timeFrame: 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)
measure: Number of patient-controlled epidural analgesia (PCEA) administered/refused
timeFrame: 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)
measure: ICU length of stay
timeFrame: From the admission to the ICU until the end of the ICU stay (or until the patient has met ICU discharge criteria).
measure: Time to postoperative mobilization
timeFrame: 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)
measure: Incidence of Nausea and vomiting
timeFrame: 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)
measure: Incidence of Pruritus
timeFrame: 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)
measure: Motor blockade
timeFrame: 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)
measure: Incidence of epidural removal
timeFrame: 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)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval
Study officials:
affiliation: CHU de Québec-Universite Laval
name: Esther Breton, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: