Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?

Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: Portable ultrasound machine

Detailed Description

Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice.

This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9W2S4
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

For Patients:

Inclusion Criteria:

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

Exclusion Criteria:

• 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:

Inclusion Criteria:

• Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Beginner Conventional (BC); Beginner level (residents) doing epidural insertions the conventional way (ie. no ultrasound scanning)
Experimental: Beginner Ultrasound (BU); Beginner level (residents) doing epidural insertions with the help of ultrasound scanning.	Device: Portable ultrasound machine; Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
No Intervention: Experienced Conventional; Experienced level (fellows) doing epidural insertions the conventional way.
Experimental: Experienced Ultrasound; Experienced level (fellows) doing epidural insertions with the help of ultrasound scanning.	Device: Portable ultrasound machine; Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 15, 2009
• First Posted (Estimate): October 16, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Ultrasound; Epidural Analgesia; Training, Inservice
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 09-02