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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Completed

Conditions: Labor Pain

Treatments: Device: Portable ultrasound machine

Study type: Interventional

Funder types: Other

Identifiers

NCT00996905

09-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

Beginner Conventional (BC)

No Intervention group

Description:

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

Beginner Ultrasound (BU)

Experimental group

Description:

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

Treatment:

Device: Portable ultrasound machine

Device: Portable ultrasound machine

Experienced Conventional

No Intervention group

Description:

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

Experienced Ultrasound

Experimental group

Description:

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

Treatment:

Device: Portable ultrasound machine

Device: Portable ultrasound machine