NCT04254523

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Analgesia, Epidural
• Pain, Postoperative

Interventions

Type	Name	Description
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 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.
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.

Timeline

• Start date: 2019-11-14
• Primary completion: 2020-05-23
• Completion: 2020-12-01
• First posted: 2020-02-05
• Last updated: 2021-01-20

Locations

1 site across 1 country: Canada