Status:
TERMINATED
Bupivacaine, Levobupivacaine and Ropivacaine After Intrathecal and Extradural Injection in Labour
Lead Sponsor:
NHS Tayside
Conditions:
Pain
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
A need exists to define the best local anesthetic and technique for pain relief in early labour. We suggest that calculating the molar Median Effective Dose for bupivacaine, levobupivacaine and ropiva...
Detailed Description
Despite 40 years of epidural analgesia, a consensus still does not exist regarding the best local anesthetic or the best technique for the provision of pain relief in early labour. Two new local anest...
Eligibility Criteria
Inclusion
- The patient is aged \> 18 years
- The patient is in early labour ≤ 5cm cervical dilatation
- The patient is American Association of Anaesthesiologists Grade I - II
- The patient provides written informed consent to participate in the trial prior to surgery
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01201213
Start Date
September 1 2009
End Date
August 1 2012
Last Update
May 31 2017
Active Locations (1)
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1
Ninewells Hospital & Medical School
Dundee, Tayside, Scotland, United Kingdom, DD19SY