Pain Relief Effects on Length of Labor

NCT01750099 | Completed

• 1 other identifier: STU 042012-035
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

Labor; analgesia; epidural; spinal

Outcome Measures

Primary Outcomes (1)

• Duration of stage I labor

  1.5 years

Secondary Outcomes (1)

• Incidence of operative vaginal delivery

  1.5 years

Other Outcomes (1)

• Incidence of cesarean delivery rate

  1.5 years

Study Arms (2)

Combined spinal-epidural

EXPERIMENTAL

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

Continuous lumbar epidural

PLACEBO COMPARATOR

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

Interventions

Combined Spinal-epidural PROCEDURE

See arm description

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

Combined spinal-epidural

Continuous Lumbar epidural PROCEDURE

See arm description

Also known as: 3 ml of 1.5% lidocaine with epinephrine 1:200000, 0.25 % bupivicaine, fentanyl

Continuous lumbar epidural

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Fentanyl; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Erica N Grant, MD

  UTSW

  PRINCIPAL INVESTIGATOR

• Kenneth Leveno, MD

  UTSW

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

US (1)