Clinical trial NCT03405311: 3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient
Official title: 3D Ultrasound-guided Labor Epidural Analgesia in the Morbid Obese Parturient: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Morbid
Pregnancy
Pain
Keywords: Labor analgesia
Ultrasound
Obesity, Morbid
Pregnancy
Labor Epidural Analgesia
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of needle insertion attempts and redirections
timeFrame: Beginning of needle insertion till catheter placement-15 minutes
measure: Successful epidural catheter placement
timeFrame: Within first 90 minutes following catheter placement
Secondary outcomes:
measure: Procedural difficulty
timeFrame: Beginning of needle insertion till catheter placement-15 minutes
measure: Needle depth
timeFrame: Beginning of needle insertion till catheter placement-15 minutes
measure: Pressure pain thresholds and pain scores
timeFrame: Before epidural placement and hospital discharge up to 3 days
measure: Complications
timeFrame: Within 30 days of admission
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch
name: Rovnat Babazade, MD
role: PRINCIPAL_INVESTIGATOR
References: