Obesity, Morbid, Pregnancy, Pain
Conditions
Keywords
Labor analgesia, Ultrasound, Obesity, Morbid, Pregnancy, Labor Epidural Analgesia
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.
Interventions
DEVICERivanna 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
OTHERPalpation
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
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Insertion Attempts Calculated Across All Participants | Beginning of needle insertion till catheter placement-15 minutes | 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 Participants With Successful Epidural Catheter Placements | Within first 90 minutes following catheter placement | Number of Participants With Successful Epidural Catheter Placements. |
| Number of Needle Insertion Redirections Calculated Across All Participants | Beginning of needle insertion till catheter placement-15 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Difficulty Rated by the Performing Anesthesiologist on a 10-point Likert Scale | Beginning of needle insertion till catheter placement-15 minutes | Procedural difficulty will be rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult). |
| Needle Depth | Beginning of needle insertion till catheter placement-15 minutes | We will also record thouy needle depth from skin and measured depth by ultrasound. |
| Pressure Pain Thresholds | Before epidural placement | Pressure pain thresholds will be obtained immediately prior to the epidural placement using the pressure pain device. |
| Number of Complications Recorded Calculated Across All Participants | Within 30 days of admission | The number of complications related to the epidural recorded within 30 days of admission. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRovnat Babazade, MD
The University of Texas Medical Branch
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed