Intrapartum Epidural Catheter Displacement: Dressing Methods

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of Intrapartum Epidural Fixation Devices: A Randomised Controlled Trial

NCT02131090

Labour Childbirth

COMPLETED NA

A Comparison Study Of Two Different Techniques For Identifying The Epidural Space In Parturients In Labour

NCT01574391

Labouring Parturients Requiring/Requesting Epidural Analgesia as Part of Their Peri-partum Care

COMPLETED NA

Epidural vs. Dural Puncture Epidural in Labor Analgesia

NCT06849726

Labor Pain Epidural Analgesia

COMPLETED NA

Obstetric Placement Study Using EST

NCT04109365

Obstetric Pain Anesthesia, Local

RECRUITING NA

Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients

NCT05977361

Analgesia, Obstetrical Post-Dural Puncture Headache

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia, Obstetrical

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TegadermTM only

Group Type ACTIVE_COMPARATOR

Tegaderm dressing only

Intervention Type DEVICE

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

Dressing with TegadermTM plus Steri-StripTM bands

Group Type ACTIVE_COMPARATOR

Tegaderm dressing + Steri-strip dressing

Intervention Type DEVICE

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

Dressing with TegadermTM plus catheter support pad.

Group Type EXPERIMENTAL

Tegaderm dressing + catheter support pad

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tegaderm dressing + catheter support pad

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

Intervention Type DEVICE

Tegaderm dressing + Steri-strip dressing

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

Intervention Type DEVICE

Tegaderm dressing only

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes