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

Not Applicable

Completed

• Conditions: Spinal Anesthesia Administration
• Interventions: Procedure: Ultrasound guidance; Procedure: Palpation of Tuffier's line; Procedure: Spinal anesthetic

• Registration Number: NCT01680913
• Lead Sponsor: University of Saskatchewan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-09-04
• Study First Posted: 2012-09-07
• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal with ultrasound guidance	Ultrasound guidance	The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
Spinal by palpation of Tuffier's line	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.
Spinal by palpation of Tuffier's line	Spinal anesthetic	Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
Spinal with ultrasound guidance	Spinal anesthetic	The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time from administration of the local anesthetic needle until free flow CSF	Up to 1 hour
Number of attempts to complete the spinal	At time of spinal anesthetic administration	As measured by new needle puncture sites, according to the anesthetist performing the procedure
Number of needle redirections	At time of spinal anesthetic administration
Number of failed blocks	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.

Trial Locations

Locations (2)

Saskatoon City Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Saint Paul's Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada