NCT03043781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

January 31, 2017

Last Update Submit

September 18, 2018

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Maternal satisfaction with treatment

    One assessment, within 24 hours of end of treatment

  • Mode of delivery

    One assessment, within 24 hours of end of treatment

  • Motor block

    One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.

  • Anesthesiologic intervention

    During treatment (0-24 hours)

  • Incidence of expected adverse events

    Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment

  • +1 more secondary outcomes

Study Arms (2)

Intermittent epidural bolus (IEB)

EXPERIMENTAL

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

Continuous epidural infusion (CEI)

ACTIVE COMPARATOR

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

Interventions

Continuous epidural infusionOTHER

Continuous infusion, 5 ml/h

Continuous epidural infusion (CEI)
Intermittent epidural bolusOTHER

Intermittent bolus 5 ml every hour

Intermittent epidural bolus (IEB)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women in labor requesting epidural analgesia
  • ASA group 1 and 2
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus UH

Lørenskog, Akershus, 1478, Norway

Location

Related 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.

    PMID: 23223119BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vegard Dahl, MD, Dr. Med.

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 6, 2017

Study Start

March 20, 2017

Primary Completion

September 5, 2018

Study Completion

September 5, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data.

Locations

NO(1)