Clinical trial NCT03574441: Intrapartum Epidural Catheter Displacement: Dressing Methods
Official title: Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia, Obstetrical
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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:

1. TegadermTM plus catheter support pad.
2. Dressing with TegadermTM plus Steri-StripTM bands
3. Dressing with TegadermTM only
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia.
2. BMI \>30 kg/m2.
3. Age older than 18 years old.

Exclusion Criteria:

1. Allergy to adhesive tape or to the components of the dressings used in the study.
2. Preexisting sensory neurologic deficits affecting lower extremities.
3. Patients taken to the operating room for cesarean section during the study period.
4. Chronic pain conditions.
5. Patients with intrathecal catheters.

Primary outcomes:
measure: Epidural Catheter Migration
timeFrame: 24 hours. The time from insertion to removal of catheter
Secondary outcomes:
measure: Rate of Epidural Catheter Replacement
timeFrame: 24 hours. The time from insertion to removal of catheter due to failure
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
References: