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Pain Relief Effects on Length of Labor

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Spinal-epidural
Continuous Lumbar epidural
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Labor, analgesia, epidural, spinal

Eligibility Criteria

16 Years - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combined spinal-epidural

Continuous lumbar epidural

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Duration of stage I labor

Secondary Outcome Measures

Incidence of operative vaginal delivery

Full Information

First Posted
December 12, 2012
Last Updated
May 23, 2014
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01750099
Brief Title
Pain Relief Effects on Length of Labor
Official Title
A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Labor, analgesia, epidural, spinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined spinal-epidural
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous lumbar epidural
Arm Type
Placebo Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Combined Spinal-epidural
Other Intervention Name(s)
Spinal dose: 1 ml of 0.25 % bupivicaine, 20 mcg of fentanyl, Epidural dose: 0.25 % bupivicaine (various amounts according to protocol), fentanyl
Intervention Description
See arm description
Intervention Type
Procedure
Intervention Name(s)
Continuous Lumbar epidural
Other Intervention Name(s)
3 ml of 1.5% lidocaine with epinephrine 1:200000, 0.25 % bupivicaine, fentanyl
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Duration of stage I labor
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Incidence of operative vaginal delivery
Time Frame
1.5 years
Other Pre-specified Outcome Measures:
Title
Incidence of cesarean delivery rate
Time Frame
1.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica N Grant, MD
Organizational Affiliation
UTSW
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Leveno, MD
Organizational Affiliation
UTSW
Official's Role
Study Director
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Pain Relief Effects on Length of Labor

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