NCT01582607

Subarachnoid Administration of Levobupivacaine for Cesarean Section

Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: University of Patras · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Stillborn Caesarean Section

Interventions

Type	Name	Description
DRUG	Bupivacaine plain	2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
DRUG	Ropivacaine plain	2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
DRUG	Levobupivacaine plain	2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
DRUG	bupivacaine plain +fentanyl	2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
DRUG	ropivacaine plain +. fentanyl	2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally
DRUG	Levobupivacaine plain +fentanyl	2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2012-04-20
• Last updated: 2012-04-20

Locations

1 site across 1 country: Greece