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

Study Overview
=================
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.

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

Conditions
-----------------
Spinal Anesthesia Administration

Intervention / Treatment
-----------------
* Procedure: Ultrasound guidance
* Procedure: Palpation of Tuffier's line
* Procedure: Spinal anesthetic


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal with ultrasound guidance<br>The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views. | Procedure: Ultrasound guidance<br>* The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.<br>Procedure: Spinal anesthetic<br>* 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.<br>|
| Active Comparator: Spinal by palpation of Tuffier's line<br>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<br>* Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.<br>Procedure: Spinal anesthetic<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |