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Completed

NCT Number: NCT03574441

Intrapartum Epidural Catheter Displacement: Dressing Methods

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.

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Key information

Conditions

Analgesia, Obstetrical Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Tegaderm dressing only

Device

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

Primary outcomes

  1. 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

  1. Rate of Epidural Catheter Replacement

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

    Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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