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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996905
• Other study ID #: 09-02
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: February 22, 2011
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Portable ultrasound machine
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
• Portable ultrasound machine
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The occurrence of inadvertent dural punctures.		24-48 hours	No
Secondary	Number of attempts to thread the epidural catheter		20 minutes	No
Secondary	Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)		2 hours	No
Secondary	The need of the anesthesiologist to call for assistance with the procedure		30 minutes	No
Secondary	Patient satisfaction as determine by a questionnaire		24 hours and 1 week	No