Intrapartum Epidural Catheter Displacement: Dressing Methods

Augusta University

Status: Completed

Conditions: Analgesia, Obstetrical

Treatments: Device: Tegaderm dressing + catheter support pad; Device: Tegaderm dressing only; Device: Tegaderm dressing + Steri-strip dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03574441

1048027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

TegadermTM only

Active Comparator group

Treatment:

Device: Tegaderm dressing only

Dressing with TegadermTM plus Steri-StripTM bands

Active Comparator group

Treatment:

Device: Tegaderm dressing + Steri-strip dressing

Dressing with TegadermTM plus catheter support pad.

Experimental group

Treatment:

Device: Tegaderm dressing + catheter support pad