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A Study on the Effect of Position on Walking Labour Epidural Efficacy

U

University of Saskatchewan

Status

Unknown

Conditions

Labor Pain
Analgesia, Epidural

Treatments

Procedure: Lumbar Epidural

Study type

Interventional

Funder types

Other

Identifiers

NCT04469101
Bio 1813

Details and patient eligibility

About

This study is being done to better understand how patient positioning can affect pain relief after an epidural. In addition to pain, the investigators will assess how position affects epidural spread, and its effects on maternal blood pressure and fetal heart rate.

Full description

Epidurals will be placed with parturients in the standard sitting position. An epidural catheter will be placed to a depth of 5 cm into the epidural space. After placement, parturients will be randomized to one of the four position groups (left uterine displacement, left lateral, right lateral, or seated upright). After successful positioning, a series of 5 cc bolus doses of 0.08% ropivacaine with 2 mcg per cc of fentanyl will be injected through the epidural catheter in 5 minute intervals for a total volume of 20 cc. After the initial loading dose of epidural solution has been injected in the first 20 minutes post-insertion, the patient will be able to return to whatever position they are most comfortable with. The parturient will be asked to rate their pain on a verbal pain scale of between 0 and 10 at the peak of their contraction at three time intervals. The spread of the blockade will be assessed with ice applied along both the left and right mid-clavicular lines. Maternal blood pressure will be measured on the upper arm in all patients as per nursing protocol. Fetal heart rate will be monitored intermittently with Doppler ultrasound as per nursing protocol.

Enrollment

216 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Active labour or admitted for induction of labour
  • Requesting an epidural for labour analgesia
  • Contractions occurring greater than once every 5 minutes

Exclusion criteria

  • Coagulation disorder
  • High risk pregnancy as per obstetrics
  • Spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

216 participants in 4 patient groups

Left Uterine Displacement
Experimental group
Description:
Supine with left tilt for uterine displacement
Treatment:
Procedure: Lumbar Epidural
Left Lateral
Experimental group
Description:
Left lateral decubitus position
Treatment:
Procedure: Lumbar Epidural
Right Lateral
Experimental group
Description:
Right lateral decubitus position
Treatment:
Procedure: Lumbar Epidural
Upright
Experimental group
Description:
Upright seated position
Treatment:
Procedure: Lumbar Epidural

Trial contacts and locations

1

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Central trial contact

Monica San Vicente, MD; Alex Stathakis, MD

Data sourced from clinicaltrials.gov

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