Intrapartum Epidural Catheter Displacement: Dressing Methods

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients

Conditions
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Analgesia, Obstetrical

Intervention / Treatment
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* Device: Tegaderm dressing + catheter support pad
* Device: Tegaderm dressing + Steri-strip dressing
* Device: Tegaderm dressing only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia. BMI >30 kg/m2. Age older than 18 years old. Exclusion Criteria: Allergy to adhesive tape or to the components of the dressings used in the study. Preexisting sensory neurologic deficits affecting lower extremities. Patients taken to the operating room for cesarean section during the study period. Chronic pain conditions. Patients with intrathecal catheters.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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: TegadermTM plus catheter support pad. Dressing with TegadermTM plus Steri-StripTM bands Dressing with TegadermTM only
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TegadermTM only<br> | Device: Tegaderm dressing only<br>* Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter<br>|
| Active Comparator: Dressing with TegadermTM plus Steri-StripTM bands<br> | Device: Tegaderm dressing + Steri-strip dressing<br>* Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter<br>|
| Experimental: Dressing with TegadermTM plus catheter support pad.<br> | Device: Tegaderm dressing + catheter support pad<br>* Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |