An interventional study of Arrow Catheter Kit. and B.Braun Catheter Kit in Labor Pain, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 257 is above the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: women in labor
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Exclusion Criteria:
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.
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
The group will be randomized to receive this labor analgesia kit.
The group will be randomized to receive this labor analgesia kit.
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.
Time frame: within 60min of first attempt at placement
Time to Thread Epidural Catheter
At the epidural placement, total amount of time required to establish successful epidural catheter thread
Time frame: 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
Time frame: within 60min of first attempt at placement
Incidence of Paresthesia
Count of participants for whom there was an incidence of paresthesia
Time frame: 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
Time frame: 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
Time frame: within 60min of first attempt at placement
Patients in labor requesting epidural analgesia for an expected vaginal delivery.
| Milestone | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| Started | 135 | 122 |
| Completed | 120 | 120 |
| Not completed | 15 | 2 |
| Withdrew: Protocol violation | 15 | 2 |
A thread is considered successful at first pass if there were no minor or major manipulations required.
| Participants | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| Number of Participants Who Experienced a Successful Thread at First Pass | 81 | 117 |
At the epidural placement, total amount of time required to establish successful epidural catheter thread
| seconds | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| Time to Thread Epidural Catheter | 135 ± 186 | 51 ± 31 |
Count of participants for whom there was an unintended dural puncture after placement
| Participants | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| Incidence of Unintended Dural Punctures | 0 | 1 |
Count of participants for whom there was an incidence of paresthesia
| Participants | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| Incidence of Paresthesia | 8 | 4 |
Count of participants for whom there was an incidence of epidural intravascular cannulation
| Participants | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| Incidence of Epidural Intravascular Cannulations | 1 | 1 |
For each participant, the number of total manipulations (major or minor) needed to successfully advance catheter
| Participants | Arrow Catheter Kit. | B.Braun Catheter Kit |
|---|---|---|
| 0 manipulations | 81 | 117 |
| 1 manipulation | 19 | 2 |
| 2 manipulations | 6 | 0 |
| 3 manipulations | 6 | 0 |
| 4 manipulations | 5 | 0 |
| 5 manipulations | 2 | 1 |
| 6 manipulations | 1 | 0 |
Collected over Within 60 minutes of first attempt at placement. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arrow Catheter Kit. | 0/120 (0%) | 0/120 (0%) | 0/120 (0%) |
| B.Braun Catheter Kit | 0/120 (0%) | 0/120 (0%) | 0/120 (0%) |
| Age, Continuous(years) | Arrow Catheter Kit. | B.Braun Catheter Kit | Total |
|---|---|---|---|
| Mean | 30 ± 5 | 30 ± 6 | 30 ± 6 |
| Sex: Female, Male(Participants) | Arrow Catheter Kit. | B.Braun Catheter Kit | Total |
|---|---|---|---|
| Female | 120 | 120 | 240 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Arrow Catheter Kit. | B.Braun Catheter Kit | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Gestational Age(weeks) | Arrow Catheter Kit. | B.Braun Catheter Kit | Total |
|---|---|---|---|
| Mean | 38.9 ± 1.5 | 38.6 ± 2.6 | 38.8 ± 2.1 |
| BMI(kg/m^2) | Arrow Catheter Kit. | B.Braun Catheter Kit | Total |
|---|---|---|---|
| Mean | 31.5 ± 5.6 | 31.6 ± 6.7 | 31.6 ± 6.2 |
| Cervical Dilation(cm) | Arrow Catheter Kit. | B.Braun Catheter Kit | Total |
|---|---|---|---|
| Mean | 4 ± 2 | 4 ± 2 | 4 ± 2 |
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Plan to share: Yes
Supporting information: Study protocol
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