A comparison of remifentanil patient-controlled analgesia with epidural analgesia during labor - A comparison of remifentanil patient-controlled analgesia with epidural analgesia during labor

Conditions: laborpain
MedDRA version: 9.1Level: LLTClassification code 10052803Term: Analgesic effect

Registration Number: EUCTR2007-000808-32-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

•Age = 18 years
•Between 37 and 42 weeks of gestation
•Singleton pregnancy
•ASA physical status I or II

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•ASA physical status = III
•Morbid obesity (BMI = 40 kg/m2)
•Substance abuse history
•High risk patients: including pre-eclampsia (diastolic pressure = 100 mmHg, proteinuria), severe asthma (daily use of medication), insulin dependent diabetes mellitus, hepatic insufficiency or renal failure
•Premature labor
•Drug allergy; history of hypersensitivity to opioid or local anesthetic substances
•Cervical dilation > 5cm

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to compare the analgesic efficacy and safety of remifentanil, administered as patient-controlled analgesia (PCA), with epidural analgesia.<br><br>The evaluation will be based upon the following outcome parameters:<br><br>A.Quality of pain relief as determined by Visual Analogue Scale scores<br>B.Patient satisfaction<br>C.Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone<br>;Secondary Objective: ;Primary end point(s): A.Quality of pain relief as determined by Visual Analogue Scale scores<br>B.Patient satisfaction<br>C.Fetal outcome as determined by Apgar scores, umbilical cord pH, NACS and requirement for naloxone<br>

Secondary Outcome Measures