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

Not Applicable

• Conditions: Labor Pain; Analgesia, Epidural
• Interventions: Procedure: Lumbar Epidural

• Registration Number: NCT04469101
• Lead Sponsor: University of Saskatchewan

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Study Start: 2021-05-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18
• Primary Completion: 2022-07
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upright	Lumbar Epidural	Upright seated position
Left Uterine Displacement	Lumbar Epidural	Supine with left tilt for uterine displacement
Right Lateral	Lumbar Epidural	Right lateral decubitus position
Left Lateral	Lumbar Epidural	Left lateral decubitus position

Primary Outcome Measures

Name	Time	Method
Labour pain based on verbal rating pain scale	Taken at time 40 minutes after epidural insertion	Pain with contractions, assessed using a 0 to 10 verbal rating pain scale; 0 being no pain with a contraction and 10 being the worse pain with a contraction.

Secondary Outcome Measures

Name	Time	Method
Category of epidural based on bilateral dermatome levels	Taken at time 40 minutes after epidural insertion	Epidural assessed if it is successful, unilateral (more than two dermatome level difference between sides), patchy (one or more areas between dermatomes that remain sensitive to temperature assessment), or failed (no measurable dermatome levels) based on the dermatome levels gathered by nursing
Assessment of epidural levels based on dermatomes	Taken at time 40 minutes after epidural insertion	Levels of analgesia assessed via temperature insensitivity to ice on the right and left side along the midclavicular lines of the patient and reported as dermatome levels.
Events of maternal hypotension after epidural placement	Blood pressure taken with a non-invasive blood pressure monitoring cuff every 5 minutes for 20 minutes after epidural insertion	Hypotensive events defined as a deviation of greater than 20% of maternal blood pressure compared to pre-epidural baseline.
Events of fetal bradycardia after epidural placement	Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion	Fetal bradycardic events defined as a fetal heart rate of less than 120 bpm after epidural placement.

Trial Locations

Locations (1)

Jim Pattison Children's Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada