NCT02793596

Brief Summary

In this study, we will set out to confirm the reliability of epidural waveform analysis (EWA) as an adjunct to loss of resistance for obstetrical epidural blocks.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

May 26, 2016

Last Update Submit

March 17, 2017

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Success rate evaluated with sensory block to ice

    15 minutes

Secondary Outcomes (1)

  • Epidural waveform analysis

    Immediately after epidural catheter insertion

Study Arms (1)

Obstetrical patients

EXPERIMENTAL

Obstetrical patients requiring epidural analgesia for delivery

Other: Obstetrical patients

Interventions

Obstetrical patientsOTHER

Epidural waveform analysis as a confirmation of loss of Resistance

Obstetrical patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists classification 1-3

You may not qualify if:

  • adults who are unable to give their own consent
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
  • allergy to local anesthetic
  • prior surgery in the lumbar spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Study Officials

  • Albert Moore, MD, FRCPC

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 8, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)