The Programmed Intermittent Epidural Bolus Adrenaline Study

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Other: Continuous epidural infusion; Other: Intermittent epidural bolus

• Registration Number: NCT03043781
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Start: 2017-03-20
• Status Verified: 2018-09
• Primary Completion: 2018-09-05
• Study Completion: 2018-09-05
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous epidural infusion (CEI)	Continuous epidural infusion	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.
Intermittent epidural bolus (IEB)	Intermittent epidural bolus	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.

Primary Outcome Measures

Name	Time	Method
Cumulative drug consumption, time adjusted	One assessment, within 24 hours of end of treatment	Cumulative drug consumption is assessed at the end of treatment (at birth). The total dose is adjusted for differences in treatment time and other possible factors of influence (BMI, parity, age, gestational age etc.)

Secondary Outcome Measures

Name	Time	Method
Maternal satisfaction with treatment	One assessment, within 24 hours of end of treatment	Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale.
Incidence of expected adverse events	Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment	Expected adverse events include hypotension (systolic blood pressure \< 90 mmHg and/or use of vasopressors), nausea (mild/moderate/severe) and pruritus (mild/moderate/severe).
Mode of delivery	One assessment, within 24 hours of end of treatment	Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.
Motor block	One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.	Extent of lower extremity motor block will be assessed using a modified Bromage score
Anesthesiologic intervention	During treatment (0-24 hours)	The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.
Pain rating	During treatment (0-24 hours)	Pain rating will be assessed using a numeric rating scale (NRS, 0-10; 0= no pain, 10=worst imaginable pain) before treatment start, at every hour for the first 8 hours of treatment and every other hour thereafter. Worst pain at delivery will also be assessed.

Trial Locations

Locations (1)

Akershus UH; 🇳🇴 Lørenskog, Akershus, Norway