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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Analgesia, Epidural
• Intervention / Treatment: Device: Programmed intermittent epidural bolus (PIEB) of bupicavaine; Device: Continuous epidural infusion (CEI) of morphine; Device: Continuous epidural infusion (CEI) of bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 2J6
    • CHU de Quebec-Universite Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Esther Breton, MD, FRCPC, CHU de Quebec-Universite Laval

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Actual): May 23, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative Period; Analgesia, Patient-Controlled; Anesthesia, Epidural
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: 2020-4832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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