Pain Relief Effects on Length of Labor

May 23, 2014 updated by: Erica Grant, University of Texas Southwestern Medical Center

A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia

This study divides patients into two groups when they ask for medicine to help relieve the pain of contractions. One group will be selected to receive an epidural and another group will be selected to receive both a spinal dose and an epidural. The investigators will then measure how long it takes to deliver the baby. The investigators think that the group that has the combination spinal and epidural will have a faster labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this randomized controlled trial, the investigators will evaluate conventional continuous lumbar epidural analgesia compared to the combined spinal-epidural analgesia. The primary outcome of interest will be duration of the active phase of the first stage of labor. Secondary outcomes include the cesarean delivery rate, operative vaginal delivery rate, analgesia requirements, maternal and neonatal safety profiles (incidence of maternal hypotension, post puncture dural headache, fetal acidemia and NICU admissions, respectively), Adequacy of maternal pain relief will also be measured using visual analog scores (VAS). The investigators hypothesize that the instantaneous pain relief that is achieved with combined spinal-epidural analgesia reduces catecholamines quickly and to a greater degree than the conventional epidural, leading to a more effective uterine contraction pattern thus decreasing the duration of the active phase of the first stage of labor.

Study Type

Interventional

Enrollment (Anticipated)

202

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
      • Dallas, Texas, United States, 75390
        • Parkland Hospital

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

16 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nulliparous women
  • Term gestation, defined as equal to or greater than 37 weeks
  • Ages 16-44 years
  • Singleton gestation
  • Cephalic presentation
  • Induction of labor on Monday 0700 through Friday 0700 at Parkland Hospital
  • Intact membranes on admission

Exclusion Criteria:

  • Chorioamnionitis at randomization
  • Intrauterine fetal death
  • Coagulopathy
  • Allergies to amide local anesthetics
  • Localized back infection

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined spinal-epidural
After verification of being in the intrathecal space with free-flow of cerebral spinal fluid, 1 mL of 0.25% bupivicaine along with 20 mcg of fentanyl will be injected into the intrathecal space. Subsequently, a B/Braun Perifix FX closed tip multiorifice flexible epidural catheter will be threaded 4 cm into the epidural space. After obtaining a T6 dermatomal level of sensory blockade, a standard solution consisting of 0.125% bupivicaine with 2 mcg of fentanyl/mL of solution will be started at 10 mL/hour with a patient controlled epidural analgesia (PCEA) option of 8 mL every 45 minutes. If a patient requires redosing, 5-10 mL of 0.25% bupivicaine will be injected slowly through epidural catheter with a goal dermatome level of T6. No systemic opioids will be given.
Procedure: Combined Spinal-epidural
See arm description
Other Names:
  • fentanyl
  • Spinal dose: 1 ml of 0.25 % bupivicaine
  • 20 mcg of fentanyl
  • Epidural dose: 0.25 % bupivicaine (various amounts according to protocol)
Placebo Comparator: Continuous lumbar epidural
After identifying the epidural space with the loss of resistance technique, a standard flexible epidural catheter will be threaded 4 cm into the epidural space. A standard test dose of 3 mL of 1.5% lidocaine with epinephrine 1:200,000 will be given through the catheter. If positive for vascular or intrathecal placement, procedure to be repeated at different interspace. If negative, catheter will be secured and slowly dosed with 5-10 mL of 0.25% bupivicaine through epidural catheter with a goal dermatome level of T6. After obtaining the dermatome level of sensory blockade, a standard solution consisting of 0.125% bupivicaine with 2 mcg of fentanyl/mL of solution will be started at 10 mL/hour with a PCEA option of 8 mL every 45 minutes. If a patient requires redosing, 5-10 mL of 0.25% bupivicaine will be injected slowly through epidural catheter with a goal dermatome level of T6. No systemic opioids will be given.
Procedure: Continuous Lumbar epidural
See arm description
Other Names:
  • fentanyl
  • 3 ml of 1.5% lidocaine with epinephrine 1:200000
  • 0.25 % bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of stage I labor
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of operative vaginal delivery
Time Frame: 1.5 years
1.5 years

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of cesarean delivery rate
Time Frame: 1.5 years
1.5 years

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Erica N Grant, MD, UTSW
  • Study Director: Kenneth Leveno, MD, UTSW

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

February 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 042012-035

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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