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NCT Number: NCT01750099

Pain Relief Effects on Length of Labor

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.

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Key information

Conditions

Labor Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

16 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Hospital

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Combined Spinal-epidural

Procedure

See arm description

Other names: Spinal dose: 1 ml of 0.25 % bupivicaine, 20 mcg of fentanyl, Epidural dose: 0.25 % bupivicaine (various amounts according to protocol), fentanyl

Continuous Lumbar epidural

Procedure

See arm description

Other names: 3 ml of 1.5% lidocaine with epinephrine 1:200000, 0.25 % bupivicaine, fentanyl

Primary outcomes

  1. Duration of stage I labor

    Time frame: 1.5 years

Secondary outcomes

  1. Incidence of operative vaginal delivery

    Time frame: 1.5 years

Other outcomes

  1. Incidence of cesarean delivery rate

    Time frame: 1.5 years

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
May 28, 2014

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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