Skip to main content
OpenTrials
Completed

NCT Number: NCT04254523

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Analgesia, Epidural Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Quebec-Universite Laval

Québec, G1R 2J6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Programmed intermittent epidural bolus (PIEB) of bupicavaine

Device

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.

Continuous epidural infusion (CEI) of bupivacaine

Device

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.

Continuous epidural infusion (CEI) of morphine

Device

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.

Primary outcomes

  1. Number of epidural infusion adjustments

    Time frame: 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)

    Number of epidural infusion adjustments by the nursing team (based on the usual protocol of our institution) will be recorded.

Secondary outcomes

  1. Quality of analgesia

    Time frame: 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)

    Pain is measured using the numeric rating scale (NRS : 0-10, 10 being the worst possible pain).

  2. Additional analgesia

    Time frame: 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)

    Prescribed additional analgesia (IV/PO/S/C opioids or other) administered to the patient while epidural analgesia is still provided.

  3. Incidence of hypotension

    Time frame: 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)

    Documented by medical records review (vitals, medication received, temporary interruption of the local anesthetic epidural infusion, IV fluids, etc.).

  4. Vasopressor use

    Time frame: 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)

    The use of vasopressor is documented by review of the medical records.

  5. Total epidural dose of local anesthetic administered

    Time frame: 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 (including additional boluses ordered by the anesthesiologist and PCEA).

  6. Total epidural dose of opioid administered

    Time frame: 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 opioid administered.

  7. Number of patient-controlled epidural analgesia (PCEA) administered/refused

    Time frame: 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)

    Number of PCEA administered/refused.

  8. ICU length of stay

    Time frame: From the admission to the ICU until the end of the ICU stay (or until the patient has met ICU discharge criteria).

    ICU length of stay

  9. Time to postoperative mobilization

    Time frame: 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)

    Time to postoperative mobilization as defined as a patient who can tolerate standing without symptoms that limit the mobilization.

  10. Incidence of Nausea and vomiting

    Time frame: 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)

    Nausea and vomiting

  11. Incidence of Pruritus

    Time frame: 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)

    Pruritus

  12. Motor blockade

    Time frame: 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)

    Bromage score is used to monitor motor blockade.

  13. Incidence of epidural removal

    Time frame: 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 epidural catheter intentionally or unintentionally withdrawn.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Major Abdominal Surgery: a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.