Clinical trial NCT03043781: The Programmed Intermittent Epidural Bolus Adrenaline Study
Official title: The Programmed Intermittent Epidural Bolus Adrenaline Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cumulative drug consumption, time adjusted
timeFrame: One assessment, within 24 hours of end of treatment
Secondary outcomes:
measure: Maternal satisfaction with treatment
timeFrame: One assessment, within 24 hours of end of treatment
measure: Mode of delivery
timeFrame: One assessment, within 24 hours of end of treatment
measure: Motor block
timeFrame: One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.
measure: Anesthesiologic intervention
timeFrame: During treatment (0-24 hours)
measure: Incidence of expected adverse events
timeFrame: Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment
measure: Pain rating
timeFrame: During treatment (0-24 hours)
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus UH
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Vegard Dahl, MD, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.