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

Not Applicable

Completed

• Conditions: Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
• Interventions: Procedure: lateral position

• Registration Number: NCT02617823
• Lead Sponsor: Region Skane

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Study Start: 2016-01
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 950

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lateral position	lateral position	experimental position to be evaluated against rutine

Primary Outcome Measures

Name	Time	Method
unilateral analgesic effect	evaluation of epidural effect after 30 min	clinical judgement: mothers pain-sensation and cold sensation test

Secondary Outcome Measures

Name	Time	Method
maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia	evaluation of epidural effect after 30 min	clinical judgement: mothers subjective wellbeing, bloodpressure and incidence of vena cava compression, neurological deficits from epidural
fetal/neonatal safety measured with CTG and APGAR score	CTG from start of study until birth, APGAR 2, 5 and 10min after birth	cardiotocographic changes and APGAR-score evaluation

Trial Locations

Locations (1)

University Hospital SUS; 🇸🇪 Malmo, Skane, Sweden