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

Not Applicable

Completed

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

• Registration Number: NCT04254523
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Primary Completion: 2020-05-23
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of epidural infusion adjustments	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 Outcome Measures

Name	Time	Method
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).	ICU length of stay
Time to postoperative 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)	Time to postoperative mobilization as defined as a patient who can tolerate standing without symptoms that limit the mobilization.
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)	Total epidural dose of opioid administered.
Incidence of 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)	Pruritus
Quality of analgesia	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).
Vasopressor use	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.
Total epidural dose of local anesthetic 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)	Total epidural dose of local anesthetic administered (including additional boluses ordered by the anesthesiologist and PCEA).
Additional analgesia	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.
Number of patient-controlled epidural analgesia (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)	Number of PCEA administered/refused.
Incidence of hypotension	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.).
Incidence of 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)	Nausea and vomiting
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)	Bromage score is used to monitor motor blockade.
Incidence of epidural removal	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.

Trial Locations

Locations (1)

CHU de Quebec-Universite Laval; 🇨🇦 Quebec, Canada