Epidural Catheter Thread Between Two Different Vendors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Arrow Catheter Kit.
* Device: B.Braun Catheter Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women in labor - Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arrow Catheter Kit.<br>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.<br>* The group will be randomized to receive this labor analgesia kit.<br>|
| Other: B.Braun Catheter Kit<br>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<br>* The group will be randomized to receive this labor analgesia kit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Thread Epidural Catheter | At the epidural placement, total amount of time required to establish successful epidural catheter thread | within 60min of first attempt at placement | 
| Incidence of Unintended Dural Punctures | Count of participants for whom there was an unintended dural puncture after placement | within 60min of first attempt at placement | 
| Incidence of Paresthesia | Count of participants for whom there was an incidence of paresthesia | within 60min of first attempt at placement | 
| Incidence of Epidural Intravascular Cannulations | Count of participants for whom there was an incidence of epidural intravascular cannulation | within 60min of first attempt at placement | 
| Epidural Needle Manipulations Needed to Successfully Advance | For each participant, the number of total manipulations (major or minor) needed to successfully advance catheter | within 60min of first attempt at placement |