The Programmed Intermittent Epidural Bolus Adrenaline Study (PIEBA)

University Hospital, Akershus

Status: Completed

Conditions: Labor Pain

Treatments: Other: Intermittent epidural bolus; Other: Continuous epidural infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03043781

2015-004397-14

Details and patient eligibility

About

This study evaluates the use of intermittent epidural boluses compared to continuous infusion in maintaining epidural pain relief in labor.

The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in both groups.

Full description

Labor is often painful for the woman going through it, and thus many women choose to have pain relief by an epidural catheter.

This is done by placing a thin plastic catheter in the epidural space in the lower back of the patient, and injecting a medicine solution usually consisting of local anesthesia and opioids.

To ensure an effective pain relief through the labor process, additional medicine solution is injected through the catheter. Traditionally, this is done by a continuous infusion, often with the addition of patient controlled boluses.

In this study the investigators investigate if maintaining the pain relief through programmed hourly intermittent boluses is more effective than continuous infusion. This is done in other studies with promising results, but the difference in this study is the addition of adrenaline to the medicine solution in order to make it more effective.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women in labor requesting epidural analgesia
• ASA group 1 and 2
• 0 or 1 previous births
• Must be at least 18 years of age.
• Singleton pregnancy
• Active labor
• Signed informed consent and expected cooperation of the patient

Exclusion criteria

• Poor communication skills in norwegian or english
• Adverse reactions to local anesthetics or synthetic opioids
• Body height below 150 cm
• Gestational age below 37 weeks, 0 days
• Any contraindication to epidural catheter placement (e.g. patients with coagulopathy, infection in area etc)
• Pre-eclampsia
• Sound reason by the investigator to suspect patient non-compliance (e.g. with use of PCEA)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Intermittent epidural bolus (IEB)

Experimental group

Description:

Bolus of 5 ml every hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.

Treatment:

Other: Intermittent epidural bolus

Continuous epidural infusion (CEI)

Active Comparator group

Description:

Continuous epidural infusion of 5 ml / hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.

Treatment:

Other: Continuous epidural infusion