Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palpation Group | Active Comparator | The palpation group will have an epidural placed after manual palpation of the spine. |
|
| Ultrasound Group | Active Comparator | The ultrasound group will have an epidural placed after identifying midline with the ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palpation | Procedure | Traditional epidural methods used for the identification of the midline using palpation prior to procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time for Epidural Placement | Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose. | Baseline up to 1 hour |
| Number of Needle Passes | Baseline up to 1 hour | |
| Total Time | Baseline up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Identify Midline | Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process. | Baseline up to 1 hour |
| Epidural Failure Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All female parturients in active labor
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark F Powell, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Department of Anesthesiology and Perioperative Medicine | Birmingham | Alabama | 35249 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Palpation Group | The palpation group will have an epidural placed after manual palpation of the spine. Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure |
| FG001 | Ultrasound Group | The ultrasound group will have an epidural placed after identifying midline with the ultrasound. Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Palpation Group | The palpation group will have an epidural placed after manual palpation of the spine. Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure |
| BG001 | Ultrasound Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time for Epidural Placement | Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose. | Posted | Mean | Standard Deviation | minutes | Baseline up to 1 hour |
|
Baseline up to 1 hour
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palpation Group | The palpation group will have an epidural placed after manual palpation of the spine. Palpation: Traditional epidural methods used for the identification of the midline using palpation prior to procedure |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Sturdivant | University of Alabama at Birmingham | 205-934-4042 | Adamsturdivant@uabmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2015 | Aug 19, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Upon enrollment into the study, participants will be randomized 1:1 to either ultrasound or palpation. Randomization will be performed via random drawing: the provider will randomly select a card assigning the method of midline identification (i.e., ultrasound or palpation). Anesthesia providers will not be randomized. Any qualified provider available to place the epidural will be the person to perform the procedure.
Not provided
Not provided
Not provided
Not provided
| Ultrasound | Device | Lumbar spinal ultrasound performed for identification of the midline prior to procedure. |
|
Comparing the number of epidural failures in the palpation vs. ultrasound group. |
| Baseline up to 1 hour |
| Number of Top-offs Required | Baseline up to 1 hour |
The ultrasound group will have an epidural placed after identifying midline with the ultrasound. Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | Centimeters |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
|
|
| Primary | Number of Needle Passes | Posted | Mean | Standard Deviation | needle passes | Baseline up to 1 hour |
|
|
|
| Primary | Total Time | Posted | Mean | Standard Deviation | Minutes | Baseline up to 1 hour |
|
|
|
| Secondary | Time to Identify Midline | Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process. | Posted | Mean | Standard Deviation | seconds | Baseline up to 1 hour |
|
|
|
| Secondary | Epidural Failure Rate | Comparing the number of epidural failures in the palpation vs. ultrasound group. | Posted | Number | failed epidurals | Baseline up to 1 hour |
|
|
|
| Secondary | Number of Top-offs Required | Posted | Mean | Standard Deviation | number of topoffs required | Baseline up to 1 hour |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Ultrasound Group | The ultrasound group will have an epidural placed after identifying midline with the ultrasound. Ultrasound: Lumbar spinal ultrasound performed for identification of the midline prior to procedure. | 0 | 75 | 0 | 75 | 0 | 75 |
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |