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Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery

L

Laval University

Status

Completed

Conditions

Pain, Postoperative
Analgesia, Epidural

Treatments

Device: Programmed intermittent epidural bolus (PIEB) of bupicavaine
Device: Continuous epidural infusion (CEI) of bupivacaine
Device: Continuous epidural infusion (CEI) of morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT04254523
2020-4832

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

88 participants in 2 patient groups

Programmed intermittent epidural bolus (PIEB)
Experimental group
Description:
Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour.
Treatment:
Device: Programmed intermittent epidural bolus (PIEB) of bupicavaine
Device: Continuous epidural infusion (CEI) of morphine
Continuous epidural infusion (CEI)
Experimental group
Description:
A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate in milliliters per hour.
Treatment:
Device: Continuous epidural infusion (CEI) of morphine
Device: Continuous epidural infusion (CEI) of bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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