Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02617823
Enrollment
950
Registered
2015-12-01
Start date
2016-01-31
Completion date
2018-12-31
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

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.

Interventions

patients placed on their left side after epidural catheter insertion

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
unilateral analgesic effectevaluation of epidural effect after 30 minclinical judgement: mothers pain-sensation and cold sensation test

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026