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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

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.

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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.

Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Beginner Conventional (BC)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Beginner Ultrasound (BU)

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

Group Type EXPERIMENTAL

Portable ultrasound machine

Intervention Type DEVICE

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

Experienced Conventional

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experienced Ultrasound

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

Group Type EXPERIMENTAL

Portable ultrasound machine

Intervention Type DEVICE

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

Interventions

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Portable ultrasound machine

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

Intervention Type DEVICE

Portable ultrasound machine

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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

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:

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes