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

This study has been completed.
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01861821
First received: June 1, 2012
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention
Labor Pain
Device: Multiport flexible catheter
Device: Uniport flexible catheter

Study Type: Interventional
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 Multiport Versus Uniport Flexible Catheter for Epidural Analgesia During Labor and Delivery

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Analgesic success rate [ Time Frame: 30 minutes following the initiation of labor epidural analgesia ] [ Designated as safety issue: No ]
    Incidence of adequate analgesia at initiation of labor epidural analgesia


Secondary Outcome Measures:
  • Inadequate analgesia at initiation of labor epidural analgesia [ Time Frame: 30 minutes following the initiation of labor epidural analgesia ] [ Designated as safety issue: No ]
  • Catheter replacement at initiation of labor epidural analgesia [ Time Frame: 45 minutes following the initiation of labor epidural analgesia ] [ Designated as safety issue: No ]
  • Adequate analgesia during the first stage of labor [ Time Frame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Visual analogue scale (VAS) pain score at the time 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 ] [ Designated as safety issue: No ]
  • Catheter replacement during the first stage of labor [ Time Frame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes ] [ Designated as safety issue: No ]
  • Adequate analgesia during the second stage of labor [ Time Frame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes ] [ Designated as safety issue: No ]
  • Inadequate analgesia during the second stage of labor [ Time Frame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes ] [ Designated as safety issue: No ]
  • Inadequate analgesia that failed epidural supplementation during the second stage of labor [ Time Frame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes ] [ Designated as safety issue: No ]
  • Anesthetic success rate [ Time Frame: 10 minutes following the initiation of epidural anesthesia for cesarean delivery ] [ Designated as safety issue: No ]
    Incidence of adequate anesthesia at initiation of epidural anesthesia for cesarean delivery

  • Inadequate anesthesia at initiation of epidural anesthesia for cesarean delivery [ Time Frame: 10 minutes following the initiation of epidural anesthesia for cesarean delivery ] [ Designated as safety issue: No ]
  • Supplementation for breakthrough pain during maintenance of epidural anesthesia for cesarean delivery [ Time Frame: The duration of cesarean delivery, an expected average of 50 minutes ] [ Designated as safety issue: No ]
  • Difficult catheter insertion [ Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes ] [ Designated as safety issue: Yes ]
  • Paresthesias [ Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes ] [ Designated as safety issue: Yes ]
  • Intravascular cannulation [ Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes ] [ Designated as safety issue: Yes ]
  • Intrathecal placement [ Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes ] [ Designated as safety issue: Yes ]
  • Difficult catheter removal [ Time Frame: The duration of epidural catheter removal, an expected average of 5 minutes ] [ Designated as safety issue: Yes ]
  • Catheter breakage [ Time Frame: The duration of epidural catheter removal, an expected average of 5 minutes ] [ Designated as safety issue: Yes ]
  • Catheter wire uncoiling [ Time Frame: The duration of epidural catheter removal, an expected average of 5 minutes ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery [ Time Frame: 24 hours following delivery ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multiport flexible catheter
Multiport flexible catheter has three ports for the delivery of epidural medication for labor analgesia
Device: Multiport flexible catheter
Multiport flexible catheter has three ports for the delivery of epidural medication
Active Comparator: Uniport flexible catheter
Uniport flexible catheter has one port for the delivery of epidural medication for labor analgesia
Device: Uniport flexible catheter
Uniport flexible catheter has one port for the delivery of epidural medication

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01861821

Locations
United States, Texas
Baylor All Saints Medical Center
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Baylor Research Institute
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: John Philip, MD Baylor Scott & White Health
  More Information

Publications:

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01861821     History of Changes
Other Study ID Numbers: 010-158
Study First Received: June 1, 2012
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Epidural catheter
Epidural analgesia
Labor epidural analgesia
Analgesic efficacy
Multiport epidural catheter
Uniport epidural catheter
Flexible epidural catheter

Additional relevant MeSH terms:
Labor Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 03, 2015