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

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Portable ultrasound machine
Portable ultrasound machine
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Epidural Analgesia, Ultrasound, Training, Inservice

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Beginner Conventional (BC)

Beginner Ultrasound (BU)

Experienced Conventional

Experienced Ultrasound

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The occurrence of inadvertent dural punctures.
Number of attempts to thread the epidural catheter
Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)
The need of the anesthesiologist to call for assistance with the procedure
Patient satisfaction as determine by a questionnaire

Full Information

First Posted
October 15, 2009
Last Updated
February 22, 2011
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00996905
Brief Title
Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?
Official Title
Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Epidural Analgesia, Ultrasound, Training, Inservice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beginner Conventional (BC)
Arm Type
No Intervention
Arm Description
Beginner level (residents) doing epidural insertions the conventional way (ie. no ultrasound scanning)
Arm Title
Beginner Ultrasound (BU)
Arm Type
Experimental
Arm Description
Beginner level (residents) doing epidural insertions with the help of ultrasound scanning.
Arm Title
Experienced Conventional
Arm Type
No Intervention
Arm Description
Experienced level (fellows) doing epidural insertions the conventional way.
Arm Title
Experienced Ultrasound
Arm Type
Experimental
Arm Description
Experienced level (fellows) doing epidural insertions with the help of ultrasound scanning.
Intervention Type
Device
Intervention Name(s)
Portable ultrasound machine
Intervention Description
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
Intervention Type
Device
Intervention Name(s)
Portable ultrasound machine
Intervention Description
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
Primary Outcome Measure Information:
Title
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.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
The occurrence of inadvertent dural punctures.
Time Frame
24-48 hours
Title
Number of attempts to thread the epidural catheter
Time Frame
20 minutes
Title
Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)
Time Frame
2 hours
Title
The need of the anesthesiologist to call for assistance with the procedure
Time Frame
30 minutes
Title
Patient satisfaction as determine by a questionnaire
Time Frame
24 hours and 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W2S4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25036283
Citation
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.
Results Reference
derived

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

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