Labor PainPhase 4IRELANNCT00710086
Intravenous Remifentanil for Labor Analgesia
A Phase 4 study testing Hydromorphone and Remifentanil in people with Labor Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Hydromorphone and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Sep 2009
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women
- > 18 years and < 45 years
- Spontaneous labor
- Analgesia request
- Epidural puncture contraindications
- Tendency of bleeding
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
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- Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization
- Diagnosed diabetes mellitus and pregnancy-induced hypertension
- Twin gestation and breech presentation
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: 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.
- Conditions
- Labor Pain
- Being tested
- Hydromorphone, Remifentanil
- Keywords
- Remifentanil, Patient-controlled analgesia, Intravenous 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.
HydromorphoneDrug
Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain
RemifentanilDrug
Also called ReiFen
Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intravenous administration of hydromorphone intermittently Receives: Drug: Hydromorphone |
| 2 | Experimental | Remifentanil intravenous patient-controlled analgesia Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Visual Analog Scale (VAS) rating of pain
Measured: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery
Secondary outcomes (15)
Rate of cesarean delivery
Measured: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Rate of instrument-assisted delivery
Measured: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Indications of cesarean delivery
Measured: Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)
Duration of analgesia
Measured: Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)
Maternal satisfaction with analgesia
Measured: At the end of the vaginal delivery (this time period underwent changing in different individuals)
Maternal oral temperature
Measured: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Use of oxytocin after analgesia
Measured: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Maximal oxytocin dose
Measured: At the end of vaginal delivery (this time period underwent changing in different individuals)
Breastfeeding success at 6 weeks after vaginal delivery
Measured: At the sixth week after successful delivery
Neonatal one-minute Apgar scale
Measured: At the first minute of baby was born
Neonatal five-minute Apgar scale
Measured: At the fifth minute of baby was born
Umbilical-cord gases analysis
Measured: At the time baby was born (0 min)
Neonatal sepsis evaluation
Measured: After the baby was born (15 min after delivery)
Neonatal antibiotic treatment
Measured: After the baby was born (one day after delivery)
Incidence of maternal side effects
Measured: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionSep 2009
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 Nanjing Medical 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710086
- Sponsor's protocol ID
- NJFY-08021MZ
- Other IDs
- NSR083
- Acronym
- IRELAN
- Status last verified
- Sep 2009
- First submitted
- 2 Jul 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women
- ClinicalTrials.gov ID
- NCT00710086
- Acronym / sponsor ID
- IRELAN / NJFY-08021MZ
- Conditions
- Labor Pain
- Keywords
- Remifentanil, Patient-controlled analgesia, Intravenous analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Jul 2008 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: HydromorphoneIntravenous administration of hydromorphone intermittently |
| 2 | Experimental | Drug: RemifentanilRemifentanil intravenous patient-controlled analgesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Nulliparous women
- > 18 years and < 45 years
- Spontaneous labor
- Analgesia request
- Epidural puncture contraindications
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| HydromorphoneIntravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain | Drug | 1 |
| RemifentanilAlso: ReiFenRemifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min. | Drug | 2 |
Primary outcome
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
15 secondary outcomes
Rate of cesarean delivery
Time frame: 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)
Indications of cesarean delivery
Time frame: 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)
Maternal satisfaction with analgesia
Time frame: 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)
Use of oxytocin after analgesia
Time frame: 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)
Breastfeeding success at 6 weeks after vaginal delivery
Time frame: At the sixth week after successful delivery
Neonatal one-minute Apgar scale
Time frame: At the first minute of baby was born
Neonatal five-minute Apgar scale
Time frame: At the fifth minute of baby was born
Umbilical-cord gases analysis
Time frame: At the time baby was born (0 min)
Neonatal sepsis evaluation
Time frame: After the baby was born (15 min after delivery)
Neonatal antibiotic treatment
Time frame: 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)
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 Sep 2009.
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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.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone and Remifentanil 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 6 inclusion and 9 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 Sep 2009. 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.
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?
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). 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 18 Sep 2009.