Pain Relief Effects on Length of Labor - Full Text View

Purpose

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.

Condition	Intervention
Labor Pain	Procedure: Combined Spinal-epidural Procedure: Continuous Lumbar epidural

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Lidocaine hydrochloride Lidocaine Racepinephrine hydrochloride Racepinephrine Fentanyl Fentanyl citrate Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

Duration of stage I labor [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of operative vaginal delivery [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:

Incidence of cesarean delivery rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	202
Study Start Date:	February 2013
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Procedure: Combined Spinal-epidural 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
Placebo Comparator: 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.	Procedure: Continuous Lumbar epidural See arm description Other Names: 3 ml of 1.5% lidocaine with epinephrine 1:200000 0.25 % bupivicaine fentanyl

Arms

Assigned Interventions

Experimental: 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.

Procedure: Combined Spinal-epidural

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

Placebo Comparator: 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.

Procedure: Continuous Lumbar epidural

See arm description

Other Names:

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

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.

Eligibility

Ages Eligible for Study:	16 Years to 44 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750099

Contacts

Contact: Erica N Grant, MD	214-786-4162	erica.grant@utsouthwestern.edu
Contact: Lisa Moseley, RN	214-648-2591	lisa.moseley@utsouthwestern.edu

Locations

United States, Texas
Parkland Hospital	Recruiting
Dallas, Texas, United States, 75390
Contact: Erica Grant, MD erica.grant@utsouthwestern.edu
Principal Investigator: Erica N Grant, MD

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:	Erica N Grant, MD	UTSW
Study Director:	Kenneth Leveno, MD	UTSW

More Information

No publications provided

Responsible Party:	Erica Grant, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT01750099 History of Changes
Other Study ID Numbers:	STU 042012-035
Study First Received:	December 12, 2012
Last Updated:	February 11, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Labor
analgesia
epidural
spinal

Additional relevant MeSH terms:

Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epinephrine
Lidocaine
Bupivacaine
Fentanyl
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 19, 2013