Pain Relief Effects on Length of Labor

This study is currently recruiting participants.
Verified February 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Erica Grant, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01750099
First received: December 12, 2012
Last updated: February 11, 2013
Last verified: February 2013

December 12, 2012
February 11, 2013
February 2013
June 2014   (final data collection date for primary outcome measure)
Duration of stage I labor [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01750099 on ClinicalTrials.gov Archive Site
Incidence of operative vaginal delivery [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Same as current
Incidence of cesarean delivery rate [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Same as current
 
Pain Relief Effects on Length of Labor
A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Labor Pain
  • 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
  • Procedure: Continuous Lumbar epidural
    See arm description
    Other Names:
    • 3 ml of 1.5% lidocaine with epinephrine 1:200000
    • 0.25 % bupivicaine
    • fentanyl
  • 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.
    Intervention: Procedure: Combined Spinal-epidural
  • 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.
    Intervention: Procedure: Continuous Lumbar epidural
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
202
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
16 Years to 44 Years
No
Contact: Erica N Grant, MD 214-786-4162 erica.grant@utsouthwestern.edu
Contact: Lisa Moseley, RN 214-648-2591 lisa.moseley@utsouthwestern.edu
United States
 
NCT01750099
STU 042012-035
No
Erica Grant, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Erica N Grant, MD UTSW
Study Director: Kenneth Leveno, MD UTSW
University of Texas Southwestern Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP