A randomised, controlled trial to determine the median effective concentration of bupivacaine, levobupivacaine and ropivacaine after intrathecal and extradural injection for pain relief in the first stage of labour

• Conditions: Pain in early labour; MedDRA version: 9.1Level: LLTClassification code 10054891Term: Epidural analgesia; MedDRA version: 9.1Level: LLTClassification code 10041536Term: Spinal anaesthesia; MedDRA version: 9.1Level: LLTClassification code 10059204Term: Labour pain

• Registration Number: EUCTR2007-001176-37-GB
• Lead Sponsor: HS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

The patient is aged > 18 years
The patient is in early labour = 5cm cervical dilitation
The patient is ASA Grade I - II
The patient provides written informed consent to participate in the trial prior to surgery

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

The patient has any known chronic medical condition for which regular medication is required
The patient has received any investigational drug within the 90 days prior
to the study or is scheduled to receive one during the study period.
The patient is scheduled for caesarean section
The patient has received opioids in the last 4 hours
The patient has evidence of alcohol or drug abuse
There is evidence of obstetric complications
The fetus has shown signs of intrauterine growth retardation
The patient has findings on pre-study evaluations (e.g. laboratory results, medical history, physical examination, ECG) that are clinically significant in the investigator’s opinion such to exclude entry into the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified