Rivanna Ultrasound for Neuraxial Block

Analgesia Clinical Trial

Official title:

Evaluation of Success in Neuraxial Block Placement Between Using Palpation of Landmark Versus Pocket-Size Handheld Ultrasound (U/S) Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214640
• Other study ID #: IRB00044968
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: April 13, 2019

Study information

• Verified date: March 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method.

Description:

Administration of (neuraxial blocks) spinal and epidural blocks is commonly achieved by first palpating the landmarks for midline with spinous process and iliac crest for L3-4-5 intervertebral spaces. With an epidural block, a loss of resistance in a pressurized syringe is used to incrementally advance the epidural needle until identification of epidural space with loss of resistance in the pressurized syringe. With a spinal block, the spinal needle is advanced incrementally until a noted "feel" of dural puncture together with return of spinal fluid via the spinal needle. The palpation technique and somewhat "blind" technique to identify the spinal and epidural spaces become more difficult and less reliable particularly with the increasing prevalence of the morbid and super-morbid obese patients. Ultrasound devices have become common and successful with non-neuraxial blocks and venous accesses, both involving mostly non-bony, soft tissues. Application of conventional ultrasound for neuraxial blocks has been limited by its bulkiness, limited imaging for bony structures and lack of automated artificial intelligent algorithm for pattern recognition. Recent technological advancement has addressed the aforementioned limitations. Rivanna Accuro is one such device that has gained FDA approval and may have helped in addressing some of these issues. It is a handheld (pocket size) U/S device with real time pattern recognition for bony structures such as the spine while providing 3-D overlay for recognition of the midline spinous process and epidural spaces and distance. The investigators hypothesize that the Rivanna Accuro or similar U/S device would reduce time to success of identifying epidural and/or intrathecal spaces as compared to conventional palpation method. We will compare placement of neuraxial block between palpation method versus ultrasound method. We will compare placement of spinal block for cesarean delivery with palpation versus with ultrasound method, and then comparing placement of neuraxial analgeisa block (combined spinal epidural analgesia) for labor analgesia with palpation versus ultrasound method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 13, 2019
• Est. primary completion date: April 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI >30

• Female requesting analgesia for delivery, be it via vaginal or cesarean delivery

Exclusion Criteria:

• Allergy to ultrasound gel

• Contraindication to receiving neuraxial analgesia

• Under the age of 18

Related Conditions & MeSH terms

• Analgesia

Intervention

Device:
• Rivanna Accuro US Device
When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.

Other:
• Palpation
When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method using conventional landmarks (spinous process and iliac crest). For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.

Procedure:
• Neuraxial Analgesia
Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
• Spinal Block
Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care

Locations

Country	Name	City	State
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Success of Neuraxial Block Placement	Time it takes to successfully identify the epidural space (defined by loss of resistance) for the groups of subjects receiving labor neuraxial analgesia; and spinal fluid flow into the hub of spinal needle for the groups of subjects receiving cesarean spinal anesthetic - length of time (in minutes) it takes to get block placed, between palpation and ultrasound groups among patients with labor neuraxial analgesia patients and cesarean spinal anesthetic, respectively and spinal fluid flow with spinal needle - length of time (in seconds) it takes to get block placed, between the 2 groups.	60-225 seconds
Secondary	Total Number of Needle Passes Per Placement	Number of needle Passes before successful placement	1 hour
Secondary	Needle Passing Success at First Attempt	Number of times of success (Number of patients) with first (single) attempt needle pass success	1 hour

External Links

•   510(k) clearance for the Rivanna Accuro handheld ultrasound device