Influence of Maternal Postioning on Spread of Local Anesthetic After Epidural Analgesia

NCT ID: NCT02617823

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

950 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals.

Detailed Description

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Pregnant women requesting epidural analgesia will be randomized to either left lateral or semi-recumbent position for 30 minutes after the first epidural bolus-injection.

After 30 minutes, the clinical effect of the analgesia will be evaluated by an anesthesiologist if available or by a midwife if the anesthesiologist is unavailable. The study-period is concluded thereafter and further positioning is optional.

Maternal and fetal wellbeing are continuously being monitored during the study period and complications/interventions registered. APGAR and CTG results during the intervention will be registered and evaluated at a later stage.

Conditions

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Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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semi-recumbent

rutine positioning at the hospital today

Group Type NO_INTERVENTION

No interventions assigned to this group

lateral position

experimental position to be evaluated against rutine

Group Type EXPERIMENTAL

lateral position

Intervention Type PROCEDURE

patients placed on their left side after epidural catheter insertion

Interventions

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lateral position

patients placed on their left side after epidural catheter insertion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all adult pregnant women recieiving epidural analgesia

Exclusion Criteria

* participation refused
* inability to understand study purpose/instructions
* study postition could not be maintained for 30 min
* ineffective epidural
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Peter Bansch

Consultant Anesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolina Samuelsson, MD, PhD

Role: STUDY_CHAIR

Region Skane, Head of the Department of Anesthesia and Intensive Care, University Hospital SUS

Locations

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University Hospital SUS

Lund, Skåne County, Sweden

Site Status

University Hospital SUS

Malmo, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SUSAN-KK

Identifier Type: -

Identifier Source: org_study_id

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