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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

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


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.




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. [ Time Frame: 20 minutes ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996905


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M9W2S4
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00996905    
Other Study ID Numbers: 09-02
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2011
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Epidural Analgesia
Ultrasound
Training, Inservice
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations