Bupivacaine, Levobupivacaine and Ropivacaine After Intrathecal and Extradural Injection in Labour

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

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 ropivacaine given both by the intrathecal (as a combined spinal epidural and epidural routes) would provide a valid comparison between the pain relieving properties of all three drugs, from which a reasoned assessment of side effects can be made.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Tayside
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine; Levobupivacaine; Ropivacaine

Criteria

Inclusion Criteria:

• 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 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