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Clinical Trial Summary

The purpose of the investigators study is to compare the clinical effects and side-effects of these three local anaesthetics as sole agents or with the supplementation with fentanyl for c-section, especially when administered in doses achieving approximately an ED 50.


Clinical Trial Description

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date .

Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01582607
Study type Interventional
Source University of Patras
Contact Kriton S Filos, Professor
Phone 2610999341
Email kritonfilos@yahoo.gr
Status Recruiting
Phase Phase 2/Phase 3
Start date January 2010
Completion date May 2012

See also
  Status Clinical Trial Phase
Recruiting NCT01558713 - Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections Phase 2/Phase 3