Pain Relief Effects on Length of Labor

NCT ID: NCT01750099

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-05-31

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Combined Spinal-epidural

Intervention Type: PROCEDURE

See arm description

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.

Group Type: PLACEBO_COMPARATOR

Continuous Lumbar epidural

Intervention Type: PROCEDURE

See arm description

Interventions

Combined Spinal-epidural

See arm description

Intervention Type: PROCEDURE

Continuous Lumbar epidural

See arm description

Intervention Type: PROCEDURE

Other Intervention Names

Spinal dose: 1 ml of 0.25 % bupivicaine; 20 mcg of fentanyl; Epidural dose: 0.25 % bupivicaine (various amounts according to protocol); fentanyl; 3 ml of 1.5% lidocaine with epinephrine 1:200000; 0.25 % bupivicaine; fentanyl

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Erica Grant

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erica N Grant, MD

Role: PRINCIPAL_INVESTIGATOR

UTSW

Kenneth Leveno, MD

Role: STUDY_DIRECTOR

UTSW

Locations

Parkland Hospital

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 042012-035

Identifier Type: -

Identifier Source: org_study_id