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

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00996905
First received: October 15, 2009
Last updated: February 22, 2011
Last verified: February 2011
  Purpose

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 Intervention
Labor Pain
Device: Portable ultrasound machine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of inadvertent dural punctures. [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
  • Number of attempts to thread the epidural catheter [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The need of the anesthesiologist to call for assistance with the procedure [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Patient satisfaction as determine by a questionnaire [ Time Frame: 24 hours and 1 week ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996905

Locations
Canada, Ontario
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, New York
  More Information

No publications provided

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00996905     History of Changes
Other Study ID Numbers: 09-02
Study First Received: October 15, 2009
Last Updated: February 22, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Epidural Analgesia
Ultrasound
Training, Inservice

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014