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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Portable ultrasound machine
* Device: Portable ultrasound machine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Analgesia, Ultrasound, Training, Inservice