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Intravenous Remifentanil for Labor Analgesia (IRELAN)

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hydromorphone
Remifentanil
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Remifentanil, Patient-controlled analgesia, Intravenous analgesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Intravenous administration of hydromorphone intermittently

Remifentanil intravenous patient-controlled analgesia

Outcomes

Primary Outcome Measures

Maternal Visual Analog Scale (VAS) rating of pain

Secondary Outcome Measures

Rate of cesarean delivery
Rate of instrument-assisted delivery
Indications of cesarean delivery
Duration of analgesia
Maternal satisfaction with analgesia
Maternal oral temperature
Use of oxytocin after analgesia
Maximal oxytocin dose
Breastfeeding success at 6 weeks after vaginal delivery
Neonatal one-minute Apgar scale
Neonatal five-minute Apgar scale
Umbilical-cord gases analysis
Neonatal sepsis evaluation
Neonatal antibiotic treatment
Incidence of maternal side effects

Full Information

First Posted
July 2, 2008
Last Updated
September 17, 2009
Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT00710086
Brief Title
Intravenous Remifentanil for Labor Analgesia
Acronym
IRELAN
Official Title
Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Remifentanil, Patient-controlled analgesia, Intravenous analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Intravenous administration of hydromorphone intermittently
Arm Title
2
Arm Type
Experimental
Arm Description
Remifentanil intravenous patient-controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
ReiFen
Intervention Description
Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Rate of cesarean delivery
Time Frame
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Title
Rate of instrument-assisted delivery
Time Frame
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Title
Indications of cesarean delivery
Time Frame
Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)
Title
Duration of analgesia
Time Frame
Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)
Title
Maternal satisfaction with analgesia
Time Frame
At the end of the vaginal delivery (this time period underwent changing in different individuals)
Title
Maternal oral temperature
Time Frame
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Title
Use of oxytocin after analgesia
Time Frame
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)
Title
Maximal oxytocin dose
Time Frame
At the end of vaginal delivery (this time period underwent changing in different individuals)
Title
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame
At the sixth week after successful delivery
Title
Neonatal one-minute Apgar scale
Time Frame
At the first minute of baby was born
Title
Neonatal five-minute Apgar scale
Time Frame
At the fifth minute of baby was born
Title
Umbilical-cord gases analysis
Time Frame
At the time baby was born (0 min)
Title
Neonatal sepsis evaluation
Time Frame
After the baby was born (15 min after delivery)
Title
Neonatal antibiotic treatment
Time Frame
After the baby was born (one day after delivery)
Title
Incidence of maternal side effects
Time Frame
Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Nulliparous women > 18 years and < 45 years Spontaneous labor Analgesia request Epidural puncture contraindications Tendency of bleeding Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Intravenous Remifentanil for Labor Analgesia

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