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Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680913
First Posted: September 7, 2012
Last Update Posted: November 15, 2016
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):
Jacelyn Larson, University of Saskatchewan
  Purpose

Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In obese patients, the commonly used landmarks may be difficult or even impossible to feel. In addition, the spine can be hidden beneath a layer of fatty tissue.

Ultrasound is useful for finding the correct injection site in pregnant patients, but the usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The potential benefits for obese patients from the use of ultrasound include shortening the duration of the procedure, increasing patient comfort, decreasing the total number of attempts, and aiding in the choice of appropriate needle length for the patient.

The investigators hypothesize that there is no difference in time to perform a spinal anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients with BMI > 35.


Condition Intervention
Spinal Anesthesia Administration Procedure: Ultrasound guidance Procedure: Palpation of Tuffier's line Procedure: Spinal anesthetic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.

Resource links provided by NLM:


Further study details as provided by Jacelyn Larson, University of Saskatchewan:

Primary Outcome Measures:
  • Total time to perform the spinal [ Time Frame: From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour. ]

Secondary Outcome Measures:
  • Time from administration of the local anesthetic needle until free flow CSF [ Time Frame: Up to 1 hour ]
  • Number of needle redirections [ Time Frame: At time of spinal anesthetic administration ]
  • Number of attempts to complete the spinal [ Time Frame: At time of spinal anesthetic administration ]
    As measured by new needle puncture sites, according to the anesthetist performing the procedure

  • Number of failed blocks [ Time Frame: Up to 15 minutes after administration of spinal anesthesia ]
    Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.


Enrollment: 67
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal with ultrasound guidance
The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
Procedure: Ultrasound guidance
The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
Procedure: Spinal anesthetic
Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.
Active Comparator: Spinal by palpation of Tuffier's line
Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
Procedure: Palpation of Tuffier's line
Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
Procedure: Spinal anesthetic
Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.

  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing surgeries amenable to spinal anesthetic
  • BMI >35
  • between the ages of 18-85

Exclusion Criteria:

  • Patients with known spinal disease or previous spinal surgery
  • Pregnant patients
  • Patients requiring emergent surgeries
  • Patients in positions other than sitting during neuroaxial anesthesia
  • Patients with contraindications to neuroaxial anesthesia
  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): NCT01680913


Locations
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
Saint Paul's Hospital
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Jacelyn Larson, MD FRCP University of Saskatchewan
  More Information

Responsible Party: Jacelyn Larson, Faculty, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01680913     History of Changes
Other Study ID Numbers: U/S spinals
First Submitted: August 28, 2012
First Posted: September 7, 2012
Last Update Posted: November 15, 2016
Last Verified: November 2016

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