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Clinical Trials/NCT03574441
NCT03574441
Completed
Not Applicable

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

Augusta University1 site in 1 country91 target enrollmentDecember 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia, Obstetrical
Sponsor
Augusta University
Enrollment
91
Locations
1
Primary Endpoint
Epidural Catheter Migration
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2017
End Date
March 18, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Efrain Riveros Perez, MD

Assistant Professor Department of Anesthesiology and Perioperative Medicine

Augusta University

Eligibility Criteria

Inclusion Criteria

  • Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia.
  • BMI \>30 kg/m
  • 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.

Outcomes

Primary Outcomes

Epidural Catheter Migration

Time Frame: 24 hours. The time from insertion to removal of catheter

Percentage of participants for whom catheter migration was observed

Secondary Outcomes

  • Rate of Epidural Catheter Replacement(24 hours. The time from insertion to removal of catheter due to failure)

Study Sites (1)

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