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Completed

NCT Number: NCT03043781

The Programmed Intermittent Epidural Bolus Adrenaline Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akershus UH

Lørenskog, Akershus, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous epidural infusion

Other

Continuous infusion, 5 ml/h

Intermittent epidural bolus

Other

Intermittent bolus 5 ml every hour

Primary outcomes

  1. Cumulative drug consumption, time adjusted

    Time frame: 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 outcomes

  1. Maternal satisfaction with treatment

    Time frame: 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.

  2. Mode of delivery

    Time frame: One assessment, within 24 hours of end of treatment

    Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.

  3. Motor block

    Time frame: 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

  4. Anesthesiologic intervention

    Time frame: During treatment (0-24 hours)

    The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.

  5. Incidence of expected adverse events

    Time frame: 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).

  6. Pain rating

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Acronym: PIEBA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2017
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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