N/A
N=257
Epidural Catheter Thread Between Two Different Vendors
Labor Pain
Bottom Line
View on ClinicalTrials.gov: NCT03722446 ↗Enrolled (actual)
257
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants Who Experienced a Successful Thread at First Pass — 81; 117 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arrow Catheter Kit. (Device); B.Braun Catheter Kit (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Successful Thread at First Pass |
81; 117 | <0.0001 sig |
| SECONDARY Time to Thread Epidural Catheter |
135; 51 | 0.01020 sig |
| SECONDARY Incidence of Unintended Dural Punctures |
0; 1 | 1.0000 |
| SECONDARY Incidence of Paresthesia |
8; 4 | 0.3753 |
| SECONDARY Incidence of Epidural Intravascular Cannulations |
1; 1 | 1.0000 |
| SECONDARY Epidural Needle Manipulations Needed to Successfully Advance |
81; 117; 19; 2; 6; 0 | <0.0001 sig |
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
Eligibility Criteria
Inclusion Criteria: women in labor
-
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT03722446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.