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Epidural Catheter Thread Between Two Different Vendors

Primary Purpose

Labor Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Arrow Catheter Kit.

B.Braun Catheter Kit

About this trial

This is an interventional prevention trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: women in labor

Exclusion Criteria:

none

Sites / Locations

von Voitlander Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arrow Catheter Kit.

B.Braun Catheter Kit

Arm Description

Arrow FlexTip Plus Epidural Catheterization Kit is a single orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.

Perifix FX Springwound Epidural Catheter Kit is a multi-orifice flex tip catheter used to place epidurals in pregnant women in labor who request an epidural for pain management in labor. This kit will be used in half of the randomized weeks.

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced a Successful Thread at First Pass

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

Secondary Outcome Measures

Time to Thread Epidural Catheter

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

Incidence of Unintended Dural Punctures

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

Incidence of Paresthesia

Count of participants for whom there was an incidence of paresthesia

Incidence of Epidural Intravascular Cannulations

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

Epidural Needle Manipulations Needed to Successfully Advance

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

Full Information

NCT ID

NCT03722446

First Posted

October 25, 2018

Last Updated

September 12, 2020

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03722446

Brief Title

Epidural Catheter Thread Between Two Different Vendors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

November 16, 2018 (Actual)

Primary Completion Date

September 21, 2019 (Actual)

Study Completion Date

September 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

257 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arrow Catheter Kit.

Arm Type

Other

Arm Description

Arm Title

B.Braun Catheter Kit

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Arrow Catheter Kit.

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

B.Braun Catheter Kit

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants Who Experienced a Successful Thread at First Pass

Description

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

Time Frame

within 60min of first attempt at placement

Secondary Outcome Measure Information:

Title

Time to Thread Epidural Catheter

Description

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

Time Frame

within 60min of first attempt at placement

Title

Incidence of Unintended Dural Punctures

Description

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

Time Frame

within 60min of first attempt at placement

Title

Incidence of Paresthesia

Description

Count of participants for whom there was an incidence of paresthesia

Time Frame

within 60min of first attempt at placement

Title

Incidence of Epidural Intravascular Cannulations

Description

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

Time Frame

within 60min of first attempt at placement

Title

Epidural Needle Manipulations Needed to Successfully Advance

Description

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

Time Frame

within 60min of first attempt at placement

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: women in labor - Exclusion Criteria: none

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlo Pancaro, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

von Voitlander Women's Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

1 year

Citations:

PubMed Identifier

33835077

Citation

Pancaro C, Purtell J, LaBuda D, Saager L, Klumpner TT, Dubovoy T, Rajala B, Singh S, Cassidy R, Vahabzadeh C, Maxwell S, Manica V, Eckmann DM, Mhyre JM, Engoren MC. Difficulty in Advancing Flexible Epidural Catheters When Establishing Labor Analgesia: An Observational Open-Label Randomized Trial. Anesth Analg. 2021 Jul 1;133(1):151-159. doi: 10.1213/ANE.0000000000005526.

Results Reference

derived

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Epidural Catheter Thread Between Two Different Vendors

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