3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Musculoskeletal, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 7/13/2018 |
| Start Date: | February 20, 2018 |
| End Date: | March 30, 2020 |
| Contact: | Rovnat Babazade, MD |
| Email: | robabaza@utmb.edu |
| Phone: | 2164826696 |
3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial
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).
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.
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.
Inclusion Criteria:
- American Society of Anesthesiologists physical status class I, II, or III.
- Term pregnancy.
- Requesting epidural analgesia for anticipated vaginal delivery.
- BMI>or = 40.
Exclusion Criteria:
- Contraindication for epidural analgesia
- Inability to adequately understand the consent form.
- Incarcerated patients.
- Patients with known spinal deformities.
- Allergies to ultrasound gel.
- Allergies to local anesthetics
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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