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Clinical Trials/NCT04469101
NCT04469101
Unknown
Not Applicable

Which Position is Best: A Randomized Clinical Trial on the Effect That Position Has on Walking Labour Epidural Analgesia

University of Saskatchewan1 site in 1 country216 target enrollmentMay 31, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Pain
Sponsor
University of Saskatchewan
Enrollment
216
Locations
1
Primary Endpoint
Labour pain based on verbal rating pain scale
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 31, 2021
End Date
October 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica San Vicente

Principal Investigator

University of Saskatchewan

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Labour pain based on verbal rating pain scale

Time Frame: 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 Outcomes

  • Category of epidural based on bilateral dermatome levels(Taken at time 40 minutes after epidural insertion)
  • Assessment of epidural levels based on dermatomes(Taken at time 40 minutes after epidural insertion)
  • 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)
  • Events of fetal bradycardia after epidural placement(Intermittent fetal heart rate monitoring via doppler as per nursing protocol for 20 minutes after epidural insertion)

Study Sites (1)

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