Comparison of Multiport Versus Uniport Soft-tip Catheter for Administering Epidural Pain Relief During Labor and Delivery
The purpose of this study is to compare the effectiveness of a Perifix FX soft-tip multiport catheter with a Perifix FX soft-tip uniport catheter at delivering analgesia during labor and delivery.The uniport catheter has a single hole at the tip of the catheter, while the multiport catheter has a closed tip and three lateral holes.
Pain During Labor and Delivery
Device: Perifix soft-tip uniport catheter
Device: Perifix soft-tip multiport
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Prospective, Controlled, Randomized, Blinded, Single-center Study of the Clinical Efficacy and Outcomes of a New Multiport Versus Uniport Soft-tip Catheter for Epidural Analgesia During Labor and Delivery|
- Incidence of complete analgesia within 30 minutes of initiating epidural analgesia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- Incidence of problems inserting catheter [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
- Incidence of catheter breakage during removal. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Perifix soft-tip uniport catheter
Soft-tip uniport catheter used to deliver epidural pain medicine. "Uniport" is the key element.
|Device: Perifix soft-tip uniport catheter|
Active Comparator: Perifix soft-tip multiport catheter
Soft-tip multiport catheter used to deliver epidural pain medicine. "Multiport" is the key element.
|Device: Perifix soft-tip multiport|
The primary outcome being studied is whether complete analgesia is achieved within 30 minutes of delivery of the loading dose. Other outcomes that will be studied include problems with insertion of the catheters and problems with removal of the catheters. Both of the catheters that are being studied are FDA-approved and in current use.
|United States, Texas|
|Baylor All Saints Medical Center|
|Fort Worth, Texas, United States, 76104|
|Principal Investigator:||John Philip, MD||Baylor Health Care Systems|