Recruiting

Epidural Efficacy

Sponsor:

University of Saskatchewan

Code:

NCT04469101

Conditions

Labor Pain

Analgesia, Epidural

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lumbar Epidural

Study Details

Brief summary:

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.

Conditions

Labor Pain

Analgesia, Epidural

Study ID

NCT04469101

Start date

May 31, 2021

Status verified date

Oct, 2021

Completion date

Oct, 2022

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Left Uterine Displacement

Supine with left tilt for uterine displacement

experimental: Left Lateral

Left lateral decubitus position

experimental: Right Lateral

Right lateral decubitus position

experimental: Upright

Upright seated position

Interventions

Lumbar Epidural

Parturients will have an epidural placed in the upright seated position as per institution standard. After epidural placement, they will be positioned as per their randomization. They will then have a total of 20 cc of epidural solution (0.08% ropivacaine with 2 mcg per cc of fentanyl) injected into the epidural in boluses of 5 cc every 5 minutes.

Primary outcome measure

  • Labour pain based on verbal rating pain scale [ Time Frame: Taken at time 0 minutes after epidural insertion ]
  • Labour pain based on verbal rating pain scale [ Time Frame: Taken at time 20 minutes after epidural insertion ]
  • Labour pain based on verbal rating pain scale [ Time Frame: Taken at time 40 minutes after epidural insertion ]

Central Contacts and Locations

Central contacts

Monica San Vicente, MD

306-655-1183mks773@mail.usask.ca

Alex Stathakis, MD

902-456-0391alex.stathakis@usask.ca

Locations

Jim Pattison Children's Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7K 1M6

Contacts

Monica San Vicente, MD

306-655-1183mks773@mail.usask.ca

Alex Stathakis, MD

306-655-1183alex.stathakis@usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

Oct 18, 2021

Last verified

Oct, 2021

Keywords

  • Analgesia, Obstetrical
  • Posture
  • Pregnancy
  • Female
  • Heart Rate, Fetal
  • Hypotension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2021-10-18.