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Rivanna Ultrasound for Neuraxial Block

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Analgesia

Treatments

Procedure: Spinal Block
Procedure: Neuraxial Analgesia
Other: Palpation
Device: Rivanna Accuro US Device

Study type

Interventional

Funder types

Other

Identifiers

NCT03214640
IRB00044968

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 4 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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