An interventional study of Rivanna Accuro 3D Ultrasound Device and Palpation in Obesity, Morbid, Pregnancy and Pain, sponsored by The University of Texas Medical Branch, Galveston. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Other: Palpation
The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Beginning of needle insertion till catheter placement-15 minutes
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).
Time frame: Beginning of needle insertion till catheter placement-15 minutes
Needle Depth
We will also record thouy needle depth from skin and measured depth by ultrasound.
Time frame: 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.
Time frame: 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.
Time frame: Within 30 days of admission
| Milestone | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| number of attempts | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Number of Needle Insertion Attempts Calculated Across All Participants | 2 | 2 |
Number of Participants With Successful Epidural Catheter Placements.
| Participants | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Number of Participants With Successful Epidural Catheter Placements | 20 | 20 |
Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult).
| score on a scale | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale | 3 (1 to 10) | 3 (1 to 10) |
We will also record thouy needle depth from skin and measured depth by ultrasound.
| cm | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Needle Depth | 7.2 ± 1.3 | 7.2 ± 1.3 |
Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device.
| Newtons | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Pressure Pain Thresholds | 48 ± 19 | 45 ± 19 |
The number of complications related to the epidural recorded within 30 days of admission.
| number of complications | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Number of Complications Recorded Calculated Across All Participants | 0 | 0 |
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.
| number of redirections | Palpation | Rivanna Accuro 3D Ultrasound Device |
|---|---|---|
| Number of Needle Insertion Redirections Calculated Across All Participants | 2 | 2 |
Collected over 3 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Palpation | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Rivanna Accuro 3D Ultrasound Device | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Palpation | Rivanna Accuro 3D Ultrasound Device | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 20 | 40 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Palpation | Rivanna Accuro 3D Ultrasound Device | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Palpation | Rivanna Accuro 3D Ultrasound Device | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 8 | 16 |
| Not Hispanic or Latino | 10 | 11 | 21 |
| Unknown or Not Reported | 2 | 1 | 3 |
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The University of Texas Medical Branch, Galveston