Intravenous Remifentanil for Labor Analgesia (IRELAN)

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: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Hydromorphone; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Maternal Visual Analog Scale (VAS) rating of pain	Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of cesarean delivery	Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Rate of instrument-assisted delivery	Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Indications of cesarean delivery	Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)
Duration of analgesia	Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)
Maternal satisfaction with analgesia	At the end of the vaginal delivery (this time period underwent changing in different individuals)
Maternal oral temperature	Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Use of oxytocin after analgesia	Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Maximal oxytocin dose	At the end of vaginal delivery (this time period underwent changing in different individuals)
Breastfeeding success at 6 weeks after vaginal delivery	At the sixth week after successful delivery
Neonatal one-minute Apgar scale	At the first minute of baby was born
Neonatal five-minute Apgar scale	At the fifth minute of baby was born
Umbilical-cord gases analysis	At the time baby was born (0 min)
Neonatal sepsis evaluation	After the baby was born (15 min after delivery)
Neonatal antibiotic treatment	After the baby was born (one day after delivery)
Incidence of maternal side effects	Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: HRSA/Maternal and Child Health Bureau

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (ESTIMATE): July 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Remifentanil; Patient-controlled analgesia; Intravenous analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil; Hydromorphone
• Other Study ID Numbers: NJFY-08021MZ; NSR083