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NCT Number: NCT01861821

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

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

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baylor All Saints Medical Center

Fort Worth, Texas, 76104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiport flexible catheter

Device

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

Uniport flexible catheter

Device

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

Primary outcomes

  1. Analgesic success rate

    Time frame: 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 outcomes

  1. Number of Clinician interventions during the first stage of labor

    Time frame: 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

  2. Anesthetic success rate

    Time frame: 10 minutes following the initiation of epidural anesthesia for cesarean delivery

    Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery

  3. Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Official study title

Prospective, Controlled, Randomized, Blinded, Single-center Study of the Clinical Efficacy and Outcomes of a Multiport Versus Uniport Flexible Catheter for Epidural Analgesia During Labor and Delivery

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 24, 2013
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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