AzTrials
AzTrials

Labor PainELAINNCT00987441

Epidural Labor Analgesia and Infant Neurobehavior

A study testing Ropivacaine and sufentanil in people with Labor Pain, run by Nanjing Medical University at 1 site in China.

Completed

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

Official record
Search all trials

Trial summary

Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Read more about this study

Who is it for?
Ages 19 to 45 years, women only
Conditions the study is for
Labor Pain
What is being tested?
Ropivacaine and sufentanil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
Sep 2009to Jul 2011
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 19 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • >18years and <45years
  • Spontaneous labor
  • Analgesia request

Who cannot join

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  • Subjects with a nonvertex presentation or scheduled induction of labor

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Nanjing Maternity and Child Health Care Hospital

    Nanjing, Jiangsu, 210004

Other trials in China

About this study

Official title: Epidural Analgesia for Labor Pain and Infant Neurobehavior

Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.

Conditions
Labor Pain
Being tested
Ropivacaine and sufentanil
Keywords
Neurobehavior, Epidural analgesia, Local anesthetic, Opioid
Medical subject headings
Labor Pain

What participants receive

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

  • Ropivacaine and sufentanilDrug

    Also called Naropin, Sufenil

    Ropivacaine 0.125% plus sufentanil 0.3 microgram

  • Ropivacaine and sufentanilDrug

    Also called Naropin, Sufenil

    Ropivacaine 0.125% plus sufentanil 0.4 microgram

  • Ropivacaine and sufentanilDrug

    Also called Naropin, Sufenil

    Ropivacaine 0.125% plus sufentanil 0.5 microgram

  • Ropivacaine and sufentanilDrug

    Also called Naropin, Sufenil

    Ropivacaine 0.0625% plus sufentanil 0.4 microgram

  • Ropivacaine and sufentanilDrug

    Also called Naropin, Sufenil

    Ropivacaine 0.1875% plus sufentanil 0.4 microgram

  • Ropivacaine and sufentanilDrug

    Also called Naropin, Sufenil

    Ropivacaine 0.25% plus sufentanil 0.4 microgram

Study groups in NCT00987441
Study groupRoleWhat they receive
Local anesthetic plus opioid 1Active comparatorLocal anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space
Receives: Drug: Ropivacaine and sufentanil
Local anesthetic plus opioid 2Active comparatorLocal anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
Receives: Drug: Ropivacaine and sufentanil
Local anesthetic plus opioid 3Active comparatorLocal anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
Receives: Drug: Ropivacaine and sufentanil
Local anesthetic 1 plus opioidActive comparatorFirst local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Receives: Drug: Ropivacaine and sufentanil
Local anesthetic 2 plus opioidActive comparatorSecond local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Receives: Drug: Ropivacaine and sufentanil
Local anesthetic 3 plus opioidActive comparatorThird local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Receives: Drug: Ropivacaine and sufentanil

What is being measured

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

  1. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Measured: Immediate after birth (0 min)

Secondary outcomes (10)

  1. Apgar scoring

    Measured: One min and 5min after birth.

  2. Umbilical-cord gases analysis

    Measured: At the time baby was born (0min)

  3. Neonatal sepsis evaluation

    Measured: One hour after the baby was born

  4. Neonatal antibiotic treatment

    Measured: One hour after the baby was born

  5. Incidence of maternal side effects

    Measured: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)

  6. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Measured: 10min after birth

  7. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Measured: 1h after birth

  8. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Measured: 8h after birth

  9. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Measured: 1d after birth

  10. Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Measured: 1wk after birth

Timeline

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

  1. First posted1 Oct 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00987441
Sponsor's protocol ID
NJMU-0933MZ
Other IDs
NMUK2191
Acronym
ELAIN
Status last verified
Jul 2011
First submitted
30 Sep 2009
Last updated
27 Jul 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine and sufentanil in people with Labor Pain, run by Nanjing Medical University at 1 site in China.

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 3 inclusion and 6 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 27 Jul 2011. 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 China. 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.

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?

Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) (time frame: Immediate after birth (0 min)). 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 NCT00987441.

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 27 Jul 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in