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Neuraxial Ultrasound Device Study

ConditionsLabor PainCesarean Delivery Regional Anesthesia Induction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorStanford University

About this trial

The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older

The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.

Patient skin is intact in the area of placement of the epidural or spinal anesthesia.

Disqualifiers

Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/μL, or evidence of infection at potential epidural site.

Presence of orthopedic implants in the spine.

Skin dyscrasias or allergies to the ultrasound procedure.

Unable to assume sitting position.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ultrasound placement device

    Device

    Device to assist in placement of epidural procedure

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Intrathecal neuraxial procedureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of difficult block placement

Difficult block placement is defined by need of \> 2 needle insertion attempts for succesful neuraxial analgesia/anesthesia

Time frame
15 minutes

Secondary outcomes

1

Incidence of failed block

Failed labor epidural analgesia and spinal anesthesia will be defined by presence of 1 or more of the following conditions: one-sided or no sensory block, pain \>3/10 after epidural placement, epidural replacement, conversion to a different form of anesthesia)

Time frame
30 minutes
2

Incidence of post-dural puncture headache

Headache developing within 7 days post block placement defined by presence of at least one of the following symptoms: posture dependent headache, symmetric headache posture dependent, neck pain posture dependent

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Rivanna Medical, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: