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The study device is not working, and there is no funding available to purchase or rent a new one.
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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).
Worldwide obesity has become an epidemic. The obstetrical population is no exception. This made more challenging for anesthesiologists on labor and delivery units to administer epidural analgesia. According to the World Health Organization, more than 30% of U.S. adults are obese with a body mass index (BMI; in kg/m2) ≥ 30. Recent data has shown that increased BMI has been associated with increased neuraxial analgesic failure and difficulty with prolonged epidural placement time.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palpation | Active Comparator | 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. |
|
| Rivanna Accuro 3D Ultrasound Device | Experimental | The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivanna Accuro 3D Ultrasound Device | Device | The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Needle Insertion Attempts Calculated Across All Participants | An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt. | Beginning of needle insertion till catheter placement-15 minutes |
| Number of Participants With Successful Epidural Catheter Placements | Number of Participants With Successful Epidural Catheter Placements. | Within first 90 minutes following catheter placement |
| Number of Needle Insertion Redirections Calculated Across All Participants | An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt. | Beginning of needle insertion till catheter placement-15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale | Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult). | Beginning of needle insertion till catheter placement-15 minutes |
| Needle Depth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rovnat Babazade, MD | The University of Texas Medical Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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| Label | URL |
|---|---|
| 510(k) clearance for the Rivanna Accuro ultrasound device | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Needle Insertion Attempts Calculated Across All Participants | An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt. | Posted | Number | number of attempts | Beginning of needle insertion till catheter placement-15 minutes |
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rovnat Babazade | University of Texas Medical Branch, Galveston | (409)772-1011 | robabaza@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2019 | Mar 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Palpation | Other | 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 |
|
We will also record thouy needle depth from skin and measured depth by ultrasound. |
| Beginning of needle insertion till catheter placement-15 minutes |
| Pressure Pain Thresholds | Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device. | Before epidural placement |
| Number of Complications Recorded Calculated Across All Participants | The number of complications related to the epidural recorded within 30 days of admission. | Within 30 days of admission |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| Primary | Number of Participants With Successful Epidural Catheter Placements | Number of Participants With Successful Epidural Catheter Placements. | Posted | Count of Participants | Participants | Within first 90 minutes following catheter placement |
|
|
|
| Secondary | Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale | Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult). | Posted | Mean | Full Range | score on a scale | Beginning of needle insertion till catheter placement-15 minutes |
|
|
|
| Secondary | Needle Depth | We will also record thouy needle depth from skin and measured depth by ultrasound. | Posted | Mean | Standard Deviation | cm | Beginning of needle insertion till catheter placement-15 minutes |
|
|
|
| Secondary | Pressure Pain Thresholds | Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device. | Posted | Median | Standard Deviation | Newtons | Before epidural placement |
|
|
|
| Secondary | Number of Complications Recorded Calculated Across All Participants | The number of complications related to the epidural recorded within 30 days of admission. | Posted | Number | number of complications | Within 30 days of admission |
|
|
|
| Primary | Number of Needle Insertion Redirections Calculated Across All Participants | An epidural insertion attempt will be defined as advancement of the needle in an effort to enter the epidural space; a needle requiring withdrawal for redirection or reinsertion through the skin/another skin puncture will be counted as an additional attempt. | Posted | Number | number of redirections | Beginning of needle insertion till catheter placement-15 minutes |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |