Analgesic Efficacy of a Multiport Versus Uniport Flexible Catheter for Labor Epidural Analgesia

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Labor Pain

Treatments: Device: Multiport flexible catheter; Device: Uniport flexible catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01861821

010-158

Details and patient eligibility

About

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

Full 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

Enrollment: 650 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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650 participants in 2 patient groups

Multiport flexible catheter

Active Comparator group

Description:

Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia

Treatment:

Device: Multiport flexible catheter

Uniport flexible catheter

Active Comparator group

Description:

Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia

Treatment:

Device: Uniport flexible catheter