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

Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia Administration
• Intervention / Treatment: Procedure: Ultrasound guidance; Procedure: Spinal anesthetic; Procedure: Palpation of Tuffier's line

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0M7
      • Saskatoon City Hospital
    • Saskatoon, Saskatchewan, Canada, S7M 0Z9
      • Saint Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from administration of the local anesthetic needle until free flow CSF		Up to 1 hour
Number of needle redirections		At time of spinal anesthetic administration
Number of attempts to complete the spinal	As measured by new needle puncture sites, according to the anesthetist performing the procedure	At time of spinal anesthetic administration
Number of failed blocks	Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.	Up to 15 minutes after administration of spinal anesthesia

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Jacelyn Larson, MD FRCP, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: September 4, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: U/S spinals