NCT02436109

Brief Summary

Most women delivering by cesarean at BC Women's receive regional anesthesia; which includes spinal, epidural, or combined spinal-epidural anesthesia. In all these techniques a needle is placed in the lower back and local anesthetic is injected to freeze the body. Normally, before the needle is placed in a patients' back, the anesthesiologist will feel between their back bones with his/her fingers to find the right spot for the needle. This study will be evaluating if the distance from the skin to the appropriate spinal space measured with a novel 3D Ultrasound will equal the actual depth of the needle insertion.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

March 31, 2015

Last Update Submit

November 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • epidural space depth

    comparison of ultrasound measured epidural space to actual needle insertion

    intraoperative

Study Arms (1)

study group

elective cesarean delivery patients

Device: Ultrasound

Interventions

Parturients backs will be scanned using 3D ultrasound to measure the depth to the epidural space

study group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • term pregnancy
  • elective cesarean

You may not qualify if:

  • scoliosis
  • high bmi

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Vit Gunka, MD FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

May 6, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations