Utility of Ultrasound in Identification of Midline and Placement of Epidural in Severely Obese Parturients: A Randomized, Prospective Study
| Registry | NCT03100968 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 150 (Actual) |
| Sponsor | University of Alabama at Birmingham (Other) |
| Conditions | Epidural Anesthesia, Spinal Ultrasound, Obesity |
| Interventions | Palpation, Ultrasound (Procedure, device) |
| Dates | start 2015-06-22, primary completion 2018-10-01, completion 2021-09-01, first posted 2017-04-04, last updated 2021-09-29 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Epidural Anesthesia All trials for Spinal Ultrasound All trials of Palpation All trials of Ultrasound
This study will address the utility of ultrasound in the placement of an epidural catheter in severely obese parturients. Identification of midline can often be difficult using the standard method of palpation in obese patients. The Investigator will determine if the use of ultrasound decreases the amount of time and number of attempts required to place the epidural.
The use of ultrasound has expanded into many areas of medicine including the identification of bony landmarks to facilitate epidural placement in obstetric anesthesia. Using ultrasound for epidural placement has become popular over the last decade with several studies being published on the topic. The likely increase in popularity for ultrasound use in the obstetric population is the need to more reliably locate bony landmarks as the traditional palpation technique has been shown to be an inaccurate way to accomplish this. Given the fact that the long-taught palpation technique can be inaccurate and studies have validated the use of ultrasound for epidural placement, ultrasound technique is routinely taught by the obstetric anesthesiologists to the anesthesiology residents at the University of Alabama at Birmingham (UAB). Also, since both techniques are considered standard practice at UAB, anesthesia providers (residents, fellows, and faculty) are free to choose either technique to locate bony structures of the back prior to epidural placement. Since no current study has specifically addressed its use in the obese pregnant patient, the investigators would like to validate its use in this population.
In this study, investigators will evaluate the use of ultrasound in the obese population to determine if its use will decrease the time it takes to place the epidural and number of attempts required when compared to the traditional palpation technique. The study will also determine the success rate of epidural placement in both the palpation and ultrasound groups.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Palpation Group | Active comparator | Procedure: Palpation | The palpation group will have an epidural placed after manual palpation of the spine. |
| Ultrasound Group | Active comparator | Device: Ultrasound | The ultrasound group will have an epidural placed after identifying midline with the ultrasound. |
Sex: Female, ages: 19 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * patient request for a labor epidural * BMI≥35 Exclusion Criteria: * BMI<35 * patient refusal of a labor epidural * coagulopathy * platelets<80,000 * prior spine procedure or instrumentation * a diagnosis of scoliosis * an intracranial or spinal mass
| Milestone | Palpation Group | Ultrasound Group |
|---|---|---|
| Started | 75 | 75 |
| Completed | 75 | 75 |
| Not completed | 0 | 0 |
Time frame: Baseline up to 1 hour
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Palpation Group | 0/75 (0.0%) | 0/75 (0.0%) | 0/75 (0.0%) |
| Ultrasound Group | 0/75 (0.0%) | 0/75 (0.0%) | 0/75 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| UAB Department of Anesthesiology and Perioperative Medicine | Birmingham, Alabama | United States |