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

August 5, 2015 updated by: Baylor Research Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saints Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic success rate
Time Frame: 30 minutes following the initiation of labor epidural analgesia
Incidence of adequate analgesia at initiation of labor epidural analgesia
30 minutes following the initiation of labor epidural analgesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inadequate analgesia at initiation of labor epidural analgesia
Time Frame: 30 minutes following the initiation of labor epidural analgesia
30 minutes following the initiation of labor epidural analgesia
Catheter replacement at initiation of labor epidural analgesia
Time Frame: 45 minutes following the initiation of labor epidural analgesia
45 minutes following the initiation of labor epidural analgesia
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
Determined from patients receiving patient controlled epidural analgesia (PCEA) who do not require clinician interventions
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
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
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
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
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
Time Frame: The duration of first stage of labor, an expected average of 6 hours and 30 minutes
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
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
The duration of first stage of labor, an expected average of 6 hours and 30 minutes
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
The duration of second stage of labor, an expected average of 1 hour and 30 minutes
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
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
Time Frame: The duration of second stage of labor, an expected average of 1 hour and 30 minutes
The duration of second stage of labor, an expected average of 1 hour and 30 minutes
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
10 minutes following the 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
10 minutes following the initiation of epidural anesthesia for cesarean delivery
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
The duration of cesarean delivery, an expected average of 50 minutes
Difficult catheter insertion
Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes
The duration of epidural catheter placement, an expected average of 15 minutes
Paresthesias
Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes
The duration of epidural catheter placement, an expected average of 15 minutes
Intravascular cannulation
Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes
The duration of epidural catheter placement, an expected average of 15 minutes
Intrathecal placement
Time Frame: The duration of epidural catheter placement, an expected average of 15 minutes
The duration of epidural catheter placement, an expected average of 15 minutes
Difficult catheter removal
Time Frame: The duration of epidural catheter removal, an expected average of 5 minutes
The duration of epidural catheter removal, an expected average of 5 minutes
Catheter breakage
Time Frame: The duration of epidural catheter removal, an expected average of 5 minutes
The duration of epidural catheter removal, an expected average of 5 minutes
Catheter wire uncoiling
Time Frame: The duration of epidural catheter removal, an expected average of 5 minutes
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
Time Frame: 24 hours following delivery
24 hours following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: John Philip, MD, Baylor Scott and White Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010-158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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