Clinical trial NCT00710086: Intravenous Remifentanil for Labor Analgesia
Official title: Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Keywords: Remifentanil
Patient-controlled analgesia
Intravenous analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2008-07-04
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maternal Visual Analog Scale (VAS) rating of pain
timeFrame: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery
Secondary outcomes:
measure: Rate of cesarean delivery
timeFrame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
measure: Rate of instrument-assisted delivery
timeFrame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
measure: Indications of cesarean delivery
timeFrame: Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)
measure: Duration of analgesia
timeFrame: Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)
measure: Maternal satisfaction with analgesia
timeFrame: At the end of the vaginal delivery (this time period underwent changing in different individuals)
measure: Maternal oral temperature
timeFrame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
measure: Use of oxytocin after analgesia
timeFrame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
measure: Maximal oxytocin dose
timeFrame: At the end of vaginal delivery (this time period underwent changing in different individuals)
measure: Breastfeeding success at 6 weeks after vaginal delivery
timeFrame: At the sixth week after successful delivery
measure: Neonatal one-minute Apgar scale
timeFrame: At the first minute of baby was born
measure: Neonatal five-minute Apgar scale
timeFrame: At the fifth minute of baby was born
measure: Umbilical-cord gases analysis
timeFrame: At the time baby was born (0 min)
measure: Neonatal sepsis evaluation
timeFrame: After the baby was born (15 min after delivery)
measure: Neonatal antibiotic treatment
timeFrame: After the baby was born (one day after delivery)
measure: Incidence of maternal side effects
timeFrame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: