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

Primary Purpose

Analgesia, Epidural, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Programmed intermittent epidural bolus (PIEB) of bupicavaine
Continuous epidural infusion (CEI) of bupivacaine
Continuous epidural infusion (CEI) of morphine
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Analgesia, Epidural focused on measuring Anesthesia, Epidural, Postoperative Period, Analgesia, Patient-Controlled

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Quebec-Universite Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Programmed intermittent epidural bolus (PIEB)

Continuous epidural infusion (CEI)

Arm Description

Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour.

A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate in milliliters per hour.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of analgesia
Pain is measured using the numeric rating scale (NRS : 0-10, 10 being the worst possible pain).
Additional analgesia
Prescribed additional analgesia (IV/PO/S/C opioids or other) administered to the patient while epidural analgesia is still provided.
Incidence of hypotension
Documented by medical records review (vitals, medication received, temporary interruption of the local anesthetic epidural infusion, IV fluids, etc.).
Vasopressor use
The use of vasopressor is documented by review of the medical records.
Total epidural dose of local anesthetic administered
Total epidural dose of local anesthetic administered (including additional boluses ordered by the anesthesiologist and PCEA).
Total epidural dose of opioid administered
Total epidural dose of opioid administered.
Number of patient-controlled epidural analgesia (PCEA) administered/refused
Number of PCEA administered/refused.
ICU length of stay
ICU length of stay
Time to postoperative mobilization
Time to postoperative mobilization as defined as a patient who can tolerate standing without symptoms that limit the mobilization.
Incidence of Nausea and vomiting
Nausea and vomiting
Incidence of Pruritus
Pruritus
Motor blockade
Bromage score is used to monitor motor blockade.
Incidence of epidural removal
Incidence of epidural catheter intentionally or unintentionally withdrawn.

Full Information

First Posted
January 22, 2020
Last Updated
January 17, 2021
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT04254523
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
May 23, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Epidural, Pain, Postoperative
Keywords
Anesthesia, Epidural, Postoperative Period, Analgesia, Patient-Controlled

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single (participant)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Programmed intermittent epidural bolus (PIEB)
Arm Type
Experimental
Arm Description
Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour.
Arm Title
Continuous epidural infusion (CEI)
Arm Type
Experimental
Arm Description
A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate in milliliters per hour.
Intervention Type
Device
Intervention Name(s)
Programmed intermittent epidural bolus (PIEB) of bupicavaine
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous epidural infusion (CEI) of bupivacaine
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous epidural infusion (CEI) of morphine
Intervention Description
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 Outcome Measure Information:
Title
Number of epidural infusion adjustments
Description
Number of epidural infusion adjustments by the nursing team (based on the usual protocol of our institution) will be recorded.
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)
Secondary Outcome Measure Information:
Title
Quality of analgesia
Description
Pain is measured using the numeric rating scale (NRS : 0-10, 10 being the worst possible pain).
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)
Title
Additional analgesia
Description
Prescribed additional analgesia (IV/PO/S/C opioids or other) administered to the patient while epidural analgesia is still provided.
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)
Title
Incidence of hypotension
Description
Documented by medical records review (vitals, medication received, temporary interruption of the local anesthetic epidural infusion, IV fluids, etc.).
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)
Title
Vasopressor use
Description
The use of vasopressor is documented by review of the medical records.
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)
Title
Total epidural dose of local anesthetic administered
Description
Total epidural dose of local anesthetic administered (including additional boluses ordered by the anesthesiologist and PCEA).
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)
Title
Total epidural dose of opioid administered
Description
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)
Title
Number of patient-controlled epidural analgesia (PCEA) administered/refused
Description
Number of 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)
Title
ICU length of stay
Description
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).
Title
Time to postoperative mobilization
Description
Time to postoperative mobilization as defined as a patient who can tolerate standing without symptoms that limit the 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)
Title
Incidence of Nausea and vomiting
Description
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)
Title
Incidence of Pruritus
Description
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)
Title
Motor blockade
Description
Bromage score is used to monitor 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)
Title
Incidence of epidural removal
Description
Incidence of epidural catheter intentionally or unintentionally withdrawn.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Breton, MD, FRCPC
Organizational Affiliation
CHU de Québec-Universite Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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