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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Analgesia, Epidural Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Single (participant)

Study Groups

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Programmed intermittent epidural bolus (PIEB)

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

Group Type EXPERIMENTAL

Programmed intermittent epidural bolus (PIEB) of bupicavaine

Intervention Type 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 morphine

Intervention Type 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.

Continuous epidural infusion (CEI)

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

Group Type EXPERIMENTAL

Continuous epidural infusion (CEI) of bupivacaine

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No