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

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617823
• Other study ID #: SUSAN-KK
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: September 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Intervention

Procedure:
• lateral position
patients placed on their left side after epidural catheter insertion

Locations

Country	Name	City	State
Sweden	University Hospital SUS	Lund	Skane
Sweden	University Hospital SUS	Malmo	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unilateral analgesic effect	clinical judgement: mothers pain-sensation and cold sensation test	evaluation of epidural effect after 30 min
Secondary	maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia	clinical judgement: mothers subjective wellbeing, bloodpressure and incidence of vena cava compression, neurological deficits from epidural	evaluation of epidural effect after 30 min
Secondary	fetal/neonatal safety measured with CTG and APGAR score	cardiotocographic changes and APGAR-score evaluation	CTG from start of study until birth, APGAR 2, 5 and 10min after birth