NCT00996905

Brief Summary

Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals. The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

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

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

October 15, 2009

Last Update Submit

February 22, 2011

Conditions

Labor Pain

Keywords

Epidural AnalgesiaUltrasoundTraining, Inservice

Outcome Measures

Primary Outcomes (1)

  • Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.

    20 minutes

Secondary Outcomes (5)

  • The occurrence of inadvertent dural punctures.

    24-48 hours

  • Number of attempts to thread the epidural catheter

    20 minutes

  • Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)

    2 hours

  • The need of the anesthesiologist to call for assistance with the procedure

    30 minutes

  • Patient satisfaction as determine by a questionnaire

    24 hours and 1 week

Study Arms (4)

Beginner Conventional (BC)

NO INTERVENTION

Beginner level (residents) doing epidural insertions the conventional way (ie. no ultrasound scanning)

Beginner Ultrasound (BU)

EXPERIMENTAL

Beginner level (residents) doing epidural insertions with the help of ultrasound scanning.

Device: Portable ultrasound machine

Experienced Conventional

NO INTERVENTION

Experienced level (fellows) doing epidural insertions the conventional way.

Experienced Ultrasound

EXPERIMENTAL

Experienced level (fellows) doing epidural insertions with the help of ultrasound scanning.

Device: Portable ultrasound machine

Interventions

Portable ultrasound machineDEVICE

Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.

Beginner Ultrasound (BU)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ability to Speak in English
  • requesting epidural analgesia for labour
  • having easily palpable spine (clinically 'easy' back)

You may not qualify if:

  • contraindications to epidural analgesia
  • patients with a history of difficult epidural insertions or spinal anesthetic
  • Patients with a known history of back surgery
  • patients with known significant kyph0scoliosis
  • For Anesthesiologists:
  • Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M9W2S4, Canada

Location

Related Publications (1)

  • Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.

    PMID: 25036283DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

CA(1)