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

• ClinicalTrials.gov Identifier: NCT00996905
• Recruitment Status: Completed
• First Posted: October 16, 2009
• Last Update Posted: February 23, 2011
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Information provided by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Tracking Information

• First Submitted Date: October 15, 2009
• First Posted Date: October 16, 2009
• Last Update Posted Date: February 23, 2011
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 15, 2009): 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. [ Time Frame: 20 minutes ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 15, 2009)

• The occurrence of inadvertent dural punctures. [ Time Frame: 24-48 hours ]
• Number of attempts to thread the epidural catheter [ Time Frame: 20 minutes ]
• Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion) [ Time Frame: 2 hours ]
• The need of the anesthesiologist to call for assistance with the procedure [ Time Frame: 30 minutes ]
• Patient satisfaction as determine by a questionnaire [ Time Frame: 24 hours and 1 week ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?
• Official Title: Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters

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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Labor Pain

Intervention

Device: Portable ultrasound machine

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

Study Arms

• 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.
  Intervention: Device: Portable ultrasound machine
• 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.
  Intervention: Device: Portable ultrasound machine

• Publications *: Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2011): 128
• Original Estimated Enrollment (submitted: October 15, 2009): 750
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00996905
• Other Study ID Numbers: 09-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
• Study Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborators: Not Provided

Investigators

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

• PRS Account: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Verification Date: February 2011