Intravenous Remifentanil for Labor Analgesia (IRELAN)

September 17, 2009 updated by: Nanjing Medical University

Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women

Labor analgesia is an essential health caring procedure for women. However, epidural analgesia cannot be performed on all subjects for different contraindications, such as lower platelet counter, back infection at the puncture site, and fear of epidural injection etc. Therefore, intravenous analgesia is an alternative for such conditions. Given the influence of intravenous administration of drugs on fetus, the drug selection is very important. Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection, which is similar in both maternal and fetal environment. Thus the fetus-associated side effects would be less than other drugs. The investigators hypothesized that remifentanil would be a superior intravenous drug used with patient-controlled technique for labor analgesia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Nulliparous women
  2. > 18 years and < 45 years
  3. Spontaneous labor
  4. Analgesia request
  5. Epidural puncture contraindications
  6. Tendency of bleeding

Exclusion Criteria:

  1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  2. Participants younger than 18 years or older than 45 years
  3. Those who were not willing to or could not finish the whole study at any time
  4. Using or used in the past 14 days of the monoamine oxidase inhibitors
  5. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  6. Subjects with a nonvertex presentation or scheduled induction of labor
  7. Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization
  8. Diagnosed diabetes mellitus and pregnancy-induced hypertension
  9. Twin gestation and breech presentation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 1
Intravenous administration of hydromorphone intermittently
Drug: Hydromorphone
Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain
EXPERIMENTAL: 2
Remifentanil intravenous patient-controlled analgesia
Drug: Remifentanil
Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.
Other Names:
  • ReiFen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maternal Visual Analog Scale (VAS) rating of pain
Time Frame: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery
Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of cesarean delivery
Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Rate of instrument-assisted delivery
Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Indications of cesarean delivery
Time Frame: Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)
Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)
Duration of analgesia
Time Frame: Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)
Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)
Maternal satisfaction with analgesia
Time Frame: At the end of the vaginal delivery (this time period underwent changing in different individuals)
At the end of the vaginal delivery (this time period underwent changing in different individuals)
Maternal oral temperature
Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Use of oxytocin after analgesia
Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Maximal oxytocin dose
Time Frame: At the end of vaginal delivery (this time period underwent changing in different individuals)
At the end of vaginal delivery (this time period underwent changing in different individuals)
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame: At the sixth week after successful delivery
At the sixth week after successful delivery
Neonatal one-minute Apgar scale
Time Frame: At the first minute of baby was born
At the first minute of baby was born
Neonatal five-minute Apgar scale
Time Frame: At the fifth minute of baby was born
At the fifth minute of baby was born
Umbilical-cord gases analysis
Time Frame: At the time baby was born (0 min)
At the time baby was born (0 min)
Neonatal sepsis evaluation
Time Frame: After the baby was born (15 min after delivery)
After the baby was born (15 min after delivery)
Neonatal antibiotic treatment
Time Frame: After the baby was born (one day after delivery)
After the baby was born (one day after delivery)
Incidence of maternal side effects
Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HRSA/Maternal and Child Health Bureau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NJFY-08021MZ
  • NSR083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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