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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01680913
First received: August 28, 2012
Last updated: February 4, 2013
Last verified: February 2013
  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: 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 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from administration of the local anesthetic needle until free flow CSF [ Time Frame: Up to 1 hour ] [ Designated as safety issue: No ]
  • Number of needle redirections [ Time Frame: At time of spinal anesthetic administration ] [ Designated as safety issue: No ]
  • Number of attempts to complete the spinal [ Time Frame: At time of spinal anesthetic administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.


Estimated Enrollment: 110
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT01680913

Contacts
Contact: Jacelyn Larson, MD FRCP (306) 655-1183 jacelyn.kolman@me.com

Locations
Canada, Saskatchewan
Saskatoon City Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Saint Paul's Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Sponsors and Collaborators
University of Saskatchewan
  More Information

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01680913     History of Changes
Other Study ID Numbers: U/S spinals
Study First Received: August 28, 2012
Last Updated: February 4, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014