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Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01865955
First Posted: May 31, 2013
Last Update Posted: February 3, 2014
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.
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  Purpose

Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.

The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.

We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.


Condition Intervention
Pregnancy Procedure: Ultrasound Device: The spinal needle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Spinal needle redirections [ Time Frame: 15 minutes ]
    Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid). A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin. The first needle pass will not be considered a redirection.


Secondary Outcome Measures:
  • Needle reinsertions [ Time Frame: 15 minutes ]
    Number of needle reinsertions defined as complete withdrawal of the spinal needle to the patient's skin followed by a new attempt in the same interspace.

  • Need to change to another interspace. [ Time Frame: 15 minutes ]
    Relocating the spinal needle to another interspace.

  • Procedure time [ Time Frame: 15 minutes ]
    Time taken to perform the spinal anesthesia, measured from insertion of the introducer needle to visualization of spinal fluid.

  • Pain score [ Time Frame: 15 minutes ]
    Verbal Numerical Pain Scores during the procedure (0-10, where 0 means no pain and 10 mean the worst pain imaginable).

  • Intervertebral level agreement [ Time Frame: 3 hours ]
    Intervertebral level agreement between L3-L4 obtained in the postoperative ultrasound assessment and the marked intervertebral level obtained pre-procedure, either by ultrasound or palpation.

  • Ultrasound Grading [ Time Frame: 3 hours ]
    Ultrasound Grading: The image pattern of the intervertebral space will be categorized into three grades by three study investigators not involved in providing the spinal anesthesia: Typical Image,Atypical Image or Inconclusive Image.


Enrollment: 100
Study Start Date: May 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Palpation
Palpation will be used to determine placement of the spinal needle.
Experimental: Ultrasound
Ultrasound will be used prior to placement of the spinal needle.
Procedure: Ultrasound
Ultrasound applied to the lumbar region to determine spinal needle placement.
Device: The spinal needle

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
  • ASA physical status 1 - 3
  • Written informed consent
  • Gestational age ≥ 37 weeks.

Exclusion Criteria:

  • Patient's refusal.
  • Body mass index ≥ 45
  • Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).
  Contacts and Locations
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): NCT01865955


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Cristian Arzola, MD Mount Sinai Hospital, New York
  More Information

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01865955     History of Changes
Other Study ID Numbers: 13-02
First Submitted: May 28, 2013
First Posted: May 31, 2013
Last Update Posted: February 3, 2014
Last Verified: January 2014

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Ultrasound
Spinal anesthesia
Cesarean section

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs