The Programmed Intermittent Epidural Bolus Adrenaline Study

Labor Pain Clinical Trial

— PIEBA  

Official title:

The Programmed Intermittent Epidural Bolus Adrenaline Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043781
• Other study ID #: 2015-004397-14
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: September 5, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• Continuous epidural infusion
Continuous infusion, 5 ml/h
• Intermittent epidural bolus
Intermittent bolus 5 ml every hour

Locations

Country	Name	City	State
Norway	Akershus UH	Lørenskog	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. Review. Erratum in: Anesth Analg. 2013 Jun;116(6):1385. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	Anesthesiologic intervention	The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.	During treatment (0-24 hours)
Secondary	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
Secondary	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)