NCT03722446

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

November 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 6, 2020

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

October 25, 2018

Results QC Date

September 12, 2020

Last Update Submit

September 12, 2020

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 60min of first attempt at placement

Secondary Outcomes (5)

  • Time to Thread Epidural Catheter

    within 60min of first attempt at placement

  • Incidence of Unintended Dural Punctures

    within 60min of first attempt at placement

  • Incidence of Paresthesia

    within 60min of first attempt at placement

  • Incidence of Epidural Intravascular Cannulations

    within 60min of first attempt at placement

  • Epidural Needle Manipulations Needed to Successfully Advance

    within 60min of first attempt at placement

Study Arms (2)

Arrow Catheter Kit.

OTHER

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.

Device: Arrow Catheter Kit.

B.Braun Catheter Kit

OTHER

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.

Device: B.Braun Catheter Kit

Interventions

Arrow Catheter Kit.DEVICE

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

Arrow Catheter Kit.
B.Braun Catheter KitDEVICE

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

B.Braun Catheter Kit

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

von Voitlander Women's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 33835077DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Carlo Pancaro
Organization
University of Michigan - Department of Anesthesiology
cpancaro@med.umich.edu
617-435-5403

Study Officials

  • Carlo Pancaro, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

November 16, 2018

Primary Completion

September 21, 2019

Study Completion

September 21, 2019

Last Updated

October 6, 2020

Results First Posted

October 6, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
1 year

Locations

US(1)