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Pain Relief Effects on Length of Labor

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01750099
Enrollment
202
Registered
2012-12-17
Start date
2013-02-28
Completion date
2014-05-31
Last updated
2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Labor, analgesia, epidural, spinal

Brief 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.

Interventions

PROCEDURECombined Spinal-epidural

See arm description

PROCEDUREContinuous Lumbar epidural

See arm description

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 44 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Duration of stage I labor1.5 years

Secondary

MeasureTime frame
Incidence of operative vaginal delivery1.5 years

Other

MeasureTime frame
Incidence of cesarean delivery rate1.5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026