The Programmed Intermittent Epidural Bolus Adrenaline Study (PIEBA)

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Other: Intermittent epidural bolus; Other: Continuous epidural infusion

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Lørenskog, Akershus, Norway, 1478
      • Akershus UH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent epidural bolus (IEB); 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.	Other: Intermittent epidural bolus; Intermittent bolus 5 ml every hour
Active Comparator: Continuous epidural infusion (CEI); 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.	Other: Continuous epidural infusion; Continuous infusion, 5 ml/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative drug consumption, time adjusted	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.)	One assessment, within 24 hours of end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal satisfaction with treatment	Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale.	One assessment, within 24 hours of end of treatment
Mode of delivery	Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.	One assessment, within 24 hours of end of treatment
Motor block	Extent of lower extremity motor block will be assessed using a modified Bromage score	One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.
Anesthesiologic intervention	The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.	During treatment (0-24 hours)
Incidence of expected adverse events	Expected adverse events include hypotension (systolic blood pressure < 90 mmHg and/or use of vasopressors), nausea (mild/moderate/severe) and pruritus (mild/moderate/severe).	Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment
Pain rating	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.	During treatment (0-24 hours)

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Principal Investigator: Vegard Dahl, MD, Dr. Med., University Hospital, Akershus

Publications and helpful links

General Publications

• George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7. Erratum In: Anesth Analg. 2013 Jun;116(6):1385.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): September 5, 2018
• Study Completion (Actual): September 5, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 2015-004397-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No