Rivanna Ultrasound for Neuraxial Block

NCT ID: NCT03214640

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2019-04-13

Brief 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.

Detailed 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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Palpation with spinal block (Group C-P)

insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery

Group Type: ACTIVE_COMPARATOR

Palpation

Intervention Type: OTHER

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.

Spinal Block

Intervention Type: PROCEDURE

Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care

Palpation with neuraxial block (Group L-P)

the needle insertion site for the neuraxial block will be identified with palpation for labor analgesia, using the spinous process and iliac crest for reference

Group Type: ACTIVE_COMPARATOR

Palpation

Intervention Type: OTHER

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.

Neuraxial Analgesia

Intervention Type: PROCEDURE

Labor analgesia will be provided utilizing the standard medications to provide labor analgesia

Rivanna Accuro Ultrasound Device with spinal block (Group C-R)

insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery

Group Type: EXPERIMENTAL

Rivanna Accuro US Device

Intervention Type: 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.

Spinal Block

Intervention Type: PROCEDURE

Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care

Rivanna Ultrasound Device with neuraxial block (Group L-R)

insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia

Group Type: EXPERIMENTAL

Rivanna Accuro US Device

Intervention Type: 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.

Neuraxial Analgesia

Intervention Type: PROCEDURE

Labor analgesia will be provided utilizing the standard medications to provide labor analgesia

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Neuraxial Analgesia

Labor analgesia will be provided utilizing the standard medications to provide labor analgesia

Intervention Type: PROCEDURE

Spinal Block

Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Pan, MD, MSEE

Role: PRINCIPAL_INVESTIGATOR

Professor, Anesthesiology

Locations

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K132736

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

Other Identifiers

IRB00044968

Identifier Type: -

Identifier Source: org_study_id