3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
NCT ID: NCT03405311
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2018-02-20
2024-01-11
Brief Summary
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Detailed Description
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The 'Blind approach' is the current standard of care in administering neuraxial anesthesia. The physician palpates the patient's spinal bony landmarks; the needle is placed in relation to identified landmarks and inserted until loss of resistance is felt. In the obese population, the success rates are as low as 68%. Recently the FDA has approved a handheld device "The Accuro" as an adjunct for neuraxial analgesia (Rivanna Medical, LLC). It consists of a three-dimensional ultrasound device. By utilizing sound waves it constructs three-dimensional images of the spinal column, allowing the physician to better see the spine in order to perform spinal/epidural anesthesia.
Hypothesize that this device will enable clinicians to assess epidural spaces for epidural needle placement compared with the traditional Blind approach in the morbidly obese parturient.
This study will be a randomized control study, with the objective to evaluate epidural analgesia success rates between the two methods (Blind Approach versus Accuro Device). Also, will determine if ultrasound based landmarks would reduce the needle tract and thereby reduced the amount of post-procedure pain at the insertion site in the peripartum period by using the algometer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Palpation
The control group (Group 2: Epidural) will receive the 'Blind/standard approach', which is the current standard of care using palpation in administering labor epidural analgesia. Additionally, an anesthesiologist will scan patient's back with Accuro device in turn off mode.
Palpation
The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
Rivanna Accuro 3D Ultrasound Device
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
Rivanna Accuro 3D Ultrasound Device
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
Interventions
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Rivanna Accuro 3D Ultrasound Device
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
Palpation
The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
Eligibility Criteria
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Inclusion Criteria
* Term pregnancy.
* Requesting epidural analgesia for anticipated vaginal delivery.
* BMI\>or = 40.
Exclusion Criteria
* Inability to adequately understand the consent form.
* Incarcerated patients.
* Patients with known spinal deformities.
* Allergies to ultrasound gel.
* Allergies to local anesthetics
18 Years
50 Years
FEMALE
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Rovnat Babazade, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Medical Branch
Locations
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The University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Related Links
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510(k) clearance for the Rivanna Accuro ultrasound device
Other Identifiers
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17-0286
Identifier Type: -
Identifier Source: org_study_id
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