Labor PainNCT01750099
Pain Relief Effects on Length of Labor
A study testing Combined Spinal-epidural and Continuous Lumbar epidural in people with Labor Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 44 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Combined Spinal-epidural and Continuous Lumbar epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Chorioamnionitis at randomization
- Intrauterine fetal death
- Coagulopathy
- Allergies to amide local anesthetics
- Localized back infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Combined Spinal-epidural, Continuous Lumbar epidural
- Keywords
- Labor, analgesia, epidural, spinal
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Spinal-epiduralProcedure or surgery
Also called Spinal dose: 1 ml of 0.25 % bupivicaine, 20 mcg of fentanyl, Epidural dose: 0.25 % bupivicaine (various amounts according to protocol), fentanyl
See arm description
Continuous Lumbar epiduralProcedure or surgery
Also called 3 ml of 1.5% lidocaine with epinephrine 1:200000, 0.25 % bupivicaine, fentanyl
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Continuous Lumbar epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of stage I labor
Measured: 1.5 years
Secondary outcomes (1)
Incidence of operative vaginal delivery
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Grant, University of Texas Southwestern Medical Center
- Investigators
- Erica N Grant, MD, Principal investigator, UTSWKenneth Leveno, MD, Study director, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750099
- Sponsor's protocol ID
- STU 042012-035
- Status last verified
- May 2014
- First submitted
- 12 Dec 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-blinded Trial of Combined Spinal-Epidural Versus Continuous Epidural Analgesia
- ClinicalTrials.gov ID
- NCT01750099
- Acronym / sponsor ID
- STU 042012-035
- Conditions
- Labor Pain
- Keywords
- Labor, analgesia, epidural, spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined spinal-epidural | Experimental | Procedure: Combined Spinal-epiduralAfter 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. |
| Continuous lumbar epidural | Placebo comparator | Procedure: Continuous Lumbar epiduralAfter 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. |
Who may qualify
- Ages
- 16 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Nulliparous women
- Term gestation, defined as equal to or greater than 37 weeks
- Ages 16-44 years
- Singleton gestation
- Cephalic presentation
Key exclusion criteria (5 listed)
- Chorioamnionitis at randomization
- Intrauterine fetal death
- Coagulopathy
- Allergies to amide local anesthetics
- Localized back infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Spinal-epiduralAlso: Spinal dose: 1 ml of 0.25 % bupivicaine, 20 mcg of fentanyl, Epidural dose: 0.25 % bupivicaine (various amounts according to protocol), fentanylSee arm description | Procedure or surgery | Combined spinal-epidural |
| Continuous Lumbar epiduralAlso: 3 ml of 1.5% lidocaine with epinephrine 1:200000, 0.25 % bupivicaine, fentanylSee arm description | Procedure or surgery | Continuous lumbar epidural |
Primary outcome
Duration of stage I labor
Time frame: 1.5 years
1 secondary outcome
Incidence of operative vaginal delivery
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica N Grant, MD principal investigator
UTSW
Kenneth Leveno, MD study director
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Spinal-epidural and Continuous Lumbar epidural in people with Labor Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of stage I labor (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.