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Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. It has been argued that prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed epidurals in obstetrics.
Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.
Primary aim: The investigators will evaluate the efficacy of three different epidural catheter dressing systems in laboring patients.
Secondary aims: To compare the effect of different degrees of obesity measured by BMI, on epidural catheter migration and quality and failure of epidural labor analgesia. To evaluate the effect of time an indwelling catheter remains in place, level of insertion and patient's height on epidural catheter migration.
Hypothesis: The use of dressing with transparent TegadermTM plus catheter support pad dressing is superior to the dressing with TegadermTM plus Steri-StripTM bands, and to a dressing with TegadermTM only, for epidural catheter fixation in laboring obese and morbidly obese patients, in terms of catheter migration. epidural quality and failure and epidural catheter replacement in the labor analgesia setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TegadermTM only | Active Comparator |
| |
| Dressing with TegadermTM plus Steri-StripTM bands | Active Comparator |
| |
| Dressing with TegadermTM plus catheter support pad. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegaderm dressing + catheter support pad | Device | Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Epidural Catheter Migration | Percentage of participants for whom catheter migration was observed | 24 hours. The time from insertion to removal of catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Epidural Catheter Replacement | Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm | 24 hours. The time from insertion to removal of catheter due to failure |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30912 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TegadermTM Only | Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter |
| FG001 | Dressing With TegadermTM Plus Steri-StripTM Bands | Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter |
| FG002 | Dressing With TegadermTM Plus Catheter Support Pad. | Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TegadermTM Only | Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter |
| BG001 | Dressing With TegadermTM Plus Steri-StripTM Bands |
| 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 | Epidural Catheter Migration | Percentage of participants for whom catheter migration was observed | Posted | Number | percentage patients catheter migration | 24 hours. The time from insertion to removal of catheter |
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TegadermTM Only | Tegaderm dressing only: Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Efrain Riveros Perez | Augusta University | 7067217361 | eriverosperez@augusta.edu |
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| 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 | Apr 17, 2017 | Jul 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Patients were randomized using a random number table to be allocated to one of three groups with sealed envelopes, based on the type of dressing to be used to secure the epidural catheter after its insertion:
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| Tegaderm dressing + Steri-strip dressing | Device | Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter |
|
| Tegaderm dressing only | Device | Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter |
|
Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
| BG002 | Dressing With TegadermTM Plus Catheter Support Pad. | Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Mean | Full Range | Weeks |
|
| Dressing With TegadermTM Plus Catheter Support Pad. |
Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter |
|
|
| Secondary | Rate of Epidural Catheter Replacement | Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm | Posted | Number | percentage of catheters | 24 hours. The time from insertion to removal of catheter due to failure |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Dressing With TegadermTM Plus Steri-StripTM Bands | Tegaderm dressing + Steri-strip dressing: Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Dressing With TegadermTM Plus Catheter Support Pad. | Tegaderm dressing + catheter support pad: Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter | 0 | 30 | 0 | 30 | 0 | 30 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |