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Completed

NCT Number: NCT02617823

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

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.

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Key information

Conditions

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital SUS, Lund, Skåne County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lateral position

Procedure

patients placed on their left side after epidural catheter insertion

Primary outcomes

  1. unilateral analgesic effect

    Time frame: evaluation of epidural effect after 30 min

    clinical judgement: mothers pain-sensation and cold sensation test

Secondary outcomes

  1. maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia

    Time frame: evaluation of epidural effect after 30 min

    clinical judgement: mothers subjective wellbeing, bloodpressure and incidence of vena cava compression, neurological deficits from epidural

  2. fetal/neonatal safety measured with CTG and APGAR score

    Time frame: CTG from start of study until birth, APGAR 2, 5 and 10min after birth

    cardiotocographic changes and APGAR-score evaluation

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2015
Registry last updated
Oct 1, 2019

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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