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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00996905
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date February 23, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Labor Pain
Intervention  ICMJE Device: Portable ultrasound machine
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2011)
128
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
750
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996905
Other Study ID Numbers  ICMJE 09-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jose Carvalho, Mount Sinai Hospital
Study Sponsor  ICMJE Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
PRS Account Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP