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

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00996905
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 10.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Device: Portable ultrasound machine; Device: Portable ultrasound machine	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. The occurrence of inadvertent dural punctures. [24-48 hours]

2. Number of attempts to thread the epidural catheter [20 minutes]

3. Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion) [2 hours]

4. The need of the anesthesiologist to call for assistance with the procedure [30 minutes]

5. Patient satisfaction as determine by a questionnaire [24 hours and 1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	Toronto	Ontario	Canada	M9W2S4

Sponsors and Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

• Principal Investigator: Jose CA Carvalho, MD, MOUNT SINAI HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00996905
• Other Study ID Numbers: 09-02
• First Posted: Oct 16, 2009
• Last Update Posted: Feb 23, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Epidural Analgesia; Ultrasound; Training, Inservice
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Feb 23, 2011