Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia
- Conditions
- Labor Pain
- Interventions
- Device: Multiport flexible catheterDevice: Uniport flexible catheter
- Registration Number
- NCT01861821
- Lead Sponsor
- Baylor Research Institute
- Brief Summary
The purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery
- Detailed Description
Multiport catheters, when compared to uniport catheters, have been associated with better analgesic quality during labor epidural analgesia because the presence of more than one port may enhance the distribution of epidural medication
Flexible catheters, when compared to rigid catheters, have been associated with better analgesic quality during labor epidural analgesia because greater flexibility may minimize catheter deviation in the epidural space, facilitate more optimal catheter placement in the epidural space, and result in better distribution of epidural medication
It is unknown whether multiple ports, which promote better distribution of epidural medication, provide added analgesic benefit to flexible catheters, which also facilitate better distribution of epidural medication, when used for the provision of epidural analgesia during labor and delivery
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 650
- American Society of Anesthesiologists Classification I-III parturients
- Mixed parity
- Estimated gestational age of at least 37 weeks
- Singleton gestation
- Cephalic presentation
- Spontaneous or induced labor
- Body mass index (BMI) > 45 kg/m2
- Prior cesarean section
- Multiple gestation
- Fetal abnormality
- Use of chronic analgesic medication
- Local anesthetic allergy
- Coagulopathy or anticoagulation
- Infection at epidural insertion site
- Spinal deformity other than mild scoliosis
- Uncontrolled/uncompensated/uncorrected cerebral, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrinologic, metabolic, or hematologic condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiport flexible catheter Multiport flexible catheter Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia Uniport flexible catheter Uniport flexible catheter Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia
- Primary Outcome Measures
Name Time Method Analgesic success rate 30 minutes following the initiation of labor epidural analgesia Incidence of adequate analgesia at initiation of labor epidural analgesia
- Secondary Outcome Measures
Name Time Method Inadequate analgesia at initiation of labor epidural analgesia 30 minutes following the initiation of labor epidural analgesia Catheter replacement at initiation of labor epidural analgesia 45 minutes following the initiation of labor epidural analgesia Adequate analgesia during the first stage of labor The duration of first stage of labor, an expected average of 6 hours and 30 minutes Determined from patients receiving patient controlled epidural analgesia (PCEA) who do not require clinician interventions
Patient controlled epidural analgesia (PCEA) demands during the first stage of labor The duration of first stage of labor, an expected average of 6 hours and 30 minutes Clinician interventions during the first stage of labor The duration of first stage of labor, an expected average of 6 hours and 30 minutes Visual analogue scale (VAS) pain score at the time of clinician interventions during the first stage of labor The duration of first stage of labor, an expected average of 6 hours and 30 minutes Catheter replacement during the first stage of labor The duration of first stage of labor, an expected average of 6 hours and 30 minutes Adequate analgesia during the second stage of labor The duration of second stage of labor, an expected average of 1 hour and 30 minutes Inadequate analgesia during the second stage of labor The duration of second stage of labor, an expected average of 1 hour and 30 minutes Inadequate analgesia that failed epidural supplementation during the second stage of labor The duration of second stage of labor, an expected average of 1 hour and 30 minutes Anesthetic success rate 10 minutes following the initiation of epidural anesthesia for cesarean delivery Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery
Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery 10 minutes following the initiation of epidural anesthesia for cesarean delivery Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery The duration of cesarean delivery, an expected average of 50 minutes Difficult catheter insertion The duration of epidural catheter placement, an expected average of 15 minutes Paresthesias The duration of epidural catheter placement, an expected average of 15 minutes Intravascular cannulation The duration of epidural catheter placement, an expected average of 15 minutes Intrathecal placement The duration of epidural catheter placement, an expected average of 15 minutes Difficult catheter removal The duration of epidural catheter removal, an expected average of 5 minutes Catheter breakage The duration of epidural catheter removal, an expected average of 5 minutes Catheter wire uncoiling The duration of epidural catheter removal, an expected average of 5 minutes Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery 24 hours following delivery
Trial Locations
- Locations (1)
Baylor All Saints Medical Center
đŸ‡ºđŸ‡¸Fort Worth, Texas, United States