Intrapartum Epidural Catheter Displacement: Dressing Methods

NCT03574441 | Completed Results FDA Device

• 1 other identifier: 1048027
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia, Obstetrical

Outcome Measures

Primary Outcomes (1)

• Epidural Catheter Migration

  Percentage of participants for whom catheter migration was observed

  24 hours. The time from insertion to removal of catheter

Secondary Outcomes (1)

• Rate of Epidural Catheter Replacement

  24 hours. The time from insertion to removal of catheter due to failure

Study Arms (3)

TegadermTM only

ACTIVE COMPARATOR

Device: Tegaderm dressing only

Dressing with TegadermTM plus Steri-StripTM bands

ACTIVE COMPARATOR

Device: Tegaderm dressing + Steri-strip dressing

Dressing with TegadermTM plus catheter support pad.

EXPERIMENTAL

Device: Tegaderm dressing + catheter support pad

Interventions

Tegaderm dressing + catheter support pad DEVICE

Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter

Dressing with TegadermTM plus catheter support pad.

Tegaderm dressing + Steri-strip dressing DEVICE

Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter

Dressing with TegadermTM plus Steri-StripTM bands

Tegaderm dressing only DEVICE

Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter

TegadermTM only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Efrain Riveros Perez
• Organization: Augusta University

eriverosperez@augusta.edu

7067217361

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Anesthesiology and Perioperative Medicine

Model Details: 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

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 2, 2018
• Study Start: December 4, 2017
• Primary Completion: March 11, 2018
• Study Completion: March 18, 2018
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)