Rivanna Ultrasound for Neuraxial Block

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Device: Rivanna Accuro US Device; Other: Palpation; Procedure: Spinal Block; Procedure: Neuraxial Analgesia

• Registration Number: NCT03214640
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2017-10-23
• Primary Completion: 2019-04-13
• Study Completion: 2019-04-13
• Status Verified: 2020-03
• Disposition First Submitted: 2020-03-23
• Results First Submitted: 2021-03-26
• Results First Submitted QC: 2021-07-07
• Disposition First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Results First Posted: 2021-07-28
• Disposition First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• BMI >30
• Female requesting analgesia for delivery, be it via vaginal or cesarean delivery

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Exclusion Criteria

• Allergy to ultrasound gel
• Contraindication to receiving neuraxial analgesia
• Under the age of 18

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palpation with spinal block (Group C-P)	Spinal Block	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery
Rivanna Accuro Ultrasound Device with spinal block (Group C-R)	Rivanna Accuro US Device	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery
Palpation with spinal block (Group C-P)	Palpation	insertion will be identified by palpation using conventional landmarks (spinous process and iliac crest) for placement of spinal block for cesarean delivery
Palpation with neuraxial block (Group L-P)	Palpation	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
Palpation with neuraxial block (Group L-P)	Neuraxial Analgesia	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
Rivanna Accuro Ultrasound Device with spinal block (Group C-R)	Spinal Block	insertion will be identified with Rivanna Accuro U/S device for placement of spinal block for cesarean delivery
Rivanna Ultrasound Device with neuraxial block (Group L-R)	Neuraxial Analgesia	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia
Rivanna Ultrasound Device with neuraxial block (Group L-R)	Rivanna Accuro US Device	insertion will be identified with Rivanna Accuro U/S device for placement of neuraxial block (combined spinal epidural) for labor analgesia

Primary Outcome Measures

Name	Time	Method
Time to Success of Neuraxial Block Placement	60-225 seconds	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.

Secondary Outcome Measures

Name	Time	Method
Total Number of Needle Passes Per Placement	1 hour	Number of needle Passes before successful placement
Needle Passing Success at First Attempt	1 hour	Number of times of success (Number of patients) with first (single) attempt needle pass success

Trial Locations

Locations (1)

Novant Health Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States