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.

Study Overview

• Status: Completed
• Conditions: Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
• Intervention / Treatment: Procedure: lateral position

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 Type: Interventional
• Enrollment (Actual): 950
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22185
      • University Hospital SUS
    • Malmo, Skane, Sweden, 20502
      • University Hospital SUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: semi-recumbent; rutine positioning at the hospital today
Experimental: lateral position; experimental position to be evaluated against rutine	Procedure: lateral position; patients placed on their left side after epidural catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
unilateral analgesic effect	clinical judgement: mothers pain-sensation and cold sensation test	evaluation of epidural effect after 30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Study Chair: Carolina Samuelsson, MD, PhD, Region Skane, Head of the Department of Anesthesia and Intensive Care, University Hospital SUS

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SUSAN-KK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO