Labor Pain
Conditions
Keywords
Epidural catheter, Epidural analgesia, Labor epidural analgesia, Analgesic efficacy, Multiport epidural catheter, Uniport epidural catheter, Flexible epidural catheter
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
Interventions
DEVICEMultiport flexible catheter
Multiport flexible catheter has three ports for the delivery of epidural medication
DEVICEUniport flexible catheter
Uniport flexible catheter has one port for the delivery of epidural medication
Sponsors
University of Texas Southwestern Medical Center
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic success rate | 30 minutes following the initiation of labor epidural analgesia | Complete analgesia is defined as the complete relief of pain during contractions following the administration of the above epidural medication without requiring further epidural medication/intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number 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 | Clinician administered rescue epidural boluses during first stage of labor |
| 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 |
| Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery | 24 hours following delivery | Subjects will be asked to evaluate the quality of labor and delivery analgesia/anesthesia as: Poor, Fair, Good, Very good, Excellent |
Countries
United States
Outcome results
None listed