Intravenous Remifentanil for Labor Analgesia

Phase 4

Completed

• Conditions: Labor Pain
• Interventions: Drug: Hydromorphone; Drug: Remifentanil

• Registration Number: NCT00710086
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hydromorphone	Intravenous administration of hydromorphone intermittently
2	Remifentanil	Remifentanil intravenous patient-controlled analgesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China