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Completed

NCT Number: NCT03722446

Epidural Catheter Thread Between Two Different Vendors

The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different epidural pain management kits vendors

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

von Voitlander Women's Hospital

Ann Arbor, Michigan, 48109, United States

About this study

The aim of the study is to assess if there is a difference in ability to thread the epidural catheter from two different pain management kits. In order to improve patient care, if there is a difference in the time to thread epidurals with one kit over the other, we would like to use the kit with decreased time to thread in the future.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

women in labor

-

Exclusion criteria

  • none

Treatment and study plan

Arrow Catheter Kit.

Device

The group will be randomized to receive this labor analgesia kit.

B.Braun Catheter Kit

Device

The group will be randomized to receive this labor analgesia kit.

Primary outcomes

  1. Number of Participants Who Experienced a Successful Thread at First Pass

    Time frame: within 60min of first attempt at placement

    A thread is considered successful at first pass if there were no minor or major manipulations required.

Secondary outcomes

  1. Time to Thread Epidural Catheter

    Time frame: within 60min of first attempt at placement

    At the epidural placement, total amount of time required to establish successful epidural catheter thread

  2. Incidence of Unintended Dural Punctures

    Time frame: within 60min of first attempt at placement

    Count of participants for whom there was an unintended dural puncture after placement

  3. Incidence of Paresthesia

    Time frame: within 60min of first attempt at placement

    Count of participants for whom there was an incidence of paresthesia

  4. Incidence of Epidural Intravascular Cannulations

    Time frame: within 60min of first attempt at placement

    Count of participants for whom there was an incidence of epidural intravascular cannulation

  5. Epidural Needle Manipulations Needed to Successfully Advance

    Time frame: within 60min of first attempt at placement

    For each participant, the number of total manipulations (major or minor) needed to successfully advance catheter

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

A Head-to-head Comparison of Catheter Thread Between Two Epidural Kit Vendors.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Oct 6, 2020

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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