Labour PainPhase 4NCT00151346

Combined Spinal-Epidural Versus Traditional Labor Epidural

A Phase 4 study testing Bupivacaine and Fentanyl (for CSE) and Bupivacaine and Fentanyl (for traditional epidural) in people with Labour Pain, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study to compare the use of spinal-epidural versus traditional labor epidural on maternal and fetal effects. The hope is to determine the safest and most effective epidural method of relieving pain during labor. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Labour Pain
What is being tested?: Bupivacaine and Fentanyl (for CSE) and Bupivacaine and Fentanyl (for traditional epidural)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 1 siteUnited States
Study dates: Oct 2003to Sep 2006
Phase: Phase 4
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 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Patient is able to read, understand and voluntarily sign the approved informed consent form (ICF) prior to any study- specific procedure;
Must be between 18 to 50 years of age.
Must be carrying a singleton fetus at term.
Must have less than a body mass index of 40.
Must be in labor, or is having a medical induction of labor.

Who cannot join

Patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.
Patient who is undergoing an elective cesarean delivery
Patient who has a presence of non-reassuring fetal status
Patient who has an abnormal or non-reassuring fetal heart rate (FHR) pattern

Trial locations and contacts

1 site in 1 country.

United States1 site

New York-Presbyterian Hospital; Weill Medical College of Cornell
New York, New York, 10065

Other trials in United States

About this study

Official title: Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects

Read the detailed description

Combined spinal-epidural anesthesia (CSE) was developed to allow excellent pain control for the pregnant woman who arrives in advanced labor and does not have much time for the anesthetic to have its effect. This has been extended recently to women in all stages of labor because of its rapid and excellent control of pain. Recent case series comparing CSE with traditional epidural have shown a slight difference in the rate of hypotension and fetal bradycardia, with the CSE technique having a higher rate of both of these side effects. This study will compare the two techniques in a prospective, randomized method.

The aim is to compare the maternal and fetal effects of two neuraxial block techniques for pain control during labor, to document blood pressure changes in upper and lower extremities pre- and post- block placement, and to document side effects (e.g. pruritus) and patient satisfaction with both techniques.

Conditions: Labour Pain
Being tested: Bupivacaine and Fentanyl (for CSE), Bupivacaine and Fentanyl (for traditional epidural)
Keywords: Epidural, Labour pain, Pregnant women, Epidural anesthesia, Labour, Obstetric, labor pain, labor, obstetric, labor analgesia
Medical subject headings: Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine and Fentanyl (for CSE)Drug
Also called combined spinal-epidural, labor analgesia
Bupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr
Bupivacaine and Fentanyl (for traditional epidural)Drug
Also called traditional epidural, labor analgesia
Bupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr

Study groups in NCT00151346
Study group	Role	What they receive
CSE	Active comparator	Subjects assigned to this group will receive "combined spinal-epidural" (CSE) to relieve pain during labor. For CSE, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer directly into the spinal canal (a smaller amount than is given for traditional epidural), followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. CSE is not experimental. Receives: Drug: Bupivacaine and Fentanyl (for CSE)
Traditional Epidural	Active comparator	Subjects assigned to this group will receive "traditional epidural" to relieve pain during labor. For the traditional epidural, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer into the epidural space, followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. The traditional epidural is not experimental. Receives: Drug: Bupivacaine and Fentanyl (for traditional epidural)

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns
Measured: during the 60 minutes after placement of analgesia

Secondary outcomes (7)

Average change in systolic blood pressure
Measured: during the 60 minutes after placement of analgesia
Average change in mean blood pressure
Measured: during the 60 minutes after placement of analgesia
Blood pressure differences between the upper and lower extremities
Measured: during the 60 minutes after placement of analgesia
Efficacy of analgesia as rated by the visual analog pain scale
Measured: during the 60 minutes after analgesic placement
Pruritus
Measured: through the first day following placement of analgesia
Incidence of hypotension
Measured: during the 60 minutes after placement of analgesia
Patient satisfaction
Measured: first day following placement of analgesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Sep 2006

First posted8 Sep 2005 (estimated)
Study startOct 2003
Primary completionSep 2006
Study completionSep 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Labour PainStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00151346
Sponsor's protocol ID: 0306006204 (0603-889)
Status last verified: Mar 2008
First submitted: 6 Sep 2005
Last updated: 18 Mar 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain

All Labour Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects
ClinicalTrials.gov ID: NCT00151346
Acronym / sponsor ID: 0306006204 (0603-889)
Conditions: Labour Pain
Keywords: Epidural, Labour pain, Pregnant women, Epidural anesthesia, Labour, Obstetric, labor pain, labor, obstetric, labor analgesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: New York Presbyterian Hospital
Study start: Oct 2003
Primary completion: Sep 2006 (actual)
Study completion: Sep 2006 (actual)
First posted: 8 Sep 2005 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
CSE	Active comparator	Drug: Bupivacaine and Fentanyl (for CSE)Subjects assigned to this group will receive "combined spinal-epidural" (CSE) to relieve pain during labor. For CSE, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer directly into the spinal canal (a smaller amount than is given for traditional epidural), followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. CSE is not experimental.
Traditional Epidural	Active comparator	Drug: Bupivacaine and Fentanyl (for traditional epidural)Subjects assigned to this group will receive "traditional epidural" to relieve pain during labor. For the traditional epidural, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer into the epidural space, followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. The traditional epidural is not experimental.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patient is able to read, understand and voluntarily sign the approved informed consent form (ICF) prior to any study- specific procedure;
Must be between 18 to 50 years of age.
Must be carrying a singleton fetus at term.
Must have less than a body mass index of 40.
Must be in labor, or is having a medical induction of labor.

Key exclusion criteria (4 listed)

Patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.
Patient who is undergoing an elective cesarean delivery
Patient who has a presence of non-reassuring fetal status
Patient who has an abnormal or non-reassuring fetal heart rate (FHR) pattern

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
Bupivacaine and Fentanyl (for CSE)Also: combined spinal-epidural, labor analgesiaBupivacaine 0.25% x 1 cc + Fentanyl 20 mcg, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr	Drug	CSE
Bupivacaine and Fentanyl (for traditional epidural)Also: traditional epidural, labor analgesiaBupivacaine 0.0625% with Fentanyl 2 mcg/mL x 15 cc, followed by infusion of Bupivacaine 0.0625% with Fentanyl 2 mcg/mL at 12 cc/hr	Drug	Traditional Epidural

Primary outcome

Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns
Time frame: during the 60 minutes after placement of analgesia

7 secondary outcomes

Average change in systolic blood pressure
Time frame: during the 60 minutes after placement of analgesia
Average change in mean blood pressure
Time frame: during the 60 minutes after placement of analgesia
Blood pressure differences between the upper and lower extremities
Time frame: during the 60 minutes after placement of analgesia
Efficacy of analgesia as rated by the visual analog pain scale
Time frame: during the 60 minutes after analgesic placement
Pruritus
Time frame: through the first day following placement of analgesia
Incidence of hypotension
Time frame: during the 60 minutes after placement of analgesia
Patient satisfaction
Time frame: first day following placement of analgesia

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 18 Mar 2008.

Related trials for Labour Pain

Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain

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.

Daniel W. Skupski, M.D. principal investigator

Obstetrics & Gynecology; Weill Medical College of Cornell - New York Presbyterian Hospital

Klaus Kjaer-Pedersen, M.D. principal investigator

Anesthesiology; Weill Medical College of Cornell - New York Presbyterian Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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 18 Mar 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns (time frame: during the 60 minutes after placement of analgesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00151346.

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 18 Mar 2008.