N/A
N=91
Intrapartum Epidural Catheter Displacement: Dressing Methods
Analgesia, Obstetrical
Bottom Line
View on ClinicalTrials.gov: NCT03574441 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Epidural Catheter Migration — 44; 25; 17 percentage patients catheter migration
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tegaderm dressing + catheter support pad (Device); Tegaderm dressing + Steri-strip dressing (Device); Tegaderm dressing only (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Augusta University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epidural Catheter Migration |
44; 25; 17 | — |
| SECONDARY Rate of Epidural Catheter Replacement |
3.2; 3.3; 3.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03574441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.