Clinical Trials Directory

Trials / Completed

CompletedNCT01750099

Pain Relief Effects on Length of Labor

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
202 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
Female
Age
16 Years – 44 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECombined Spinal-epiduralSee arm description
PROCEDUREContinuous Lumbar epiduralSee arm description

Timeline

Start date
2013-02-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2012-12-17
Last updated
2014-05-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01750099. Inclusion in this directory is not an endorsement.