NCT01558713

Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections

Assessment of Sensory and Motor Block After Intrathecal Administration of Bupivacaine, Ropivacaine and Levo-bupivacaine Combined With Small Doses of Fentanyl, Followed by Administration of Normal Saline Epidurally:a Clinical Trial in Parturients Scheduled for C-section

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Patras · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.

Detailed description

Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.

Conditions

• Stillborn Caesarean Section

Interventions

Type	Name	Description
DRUG	Bupivacaine- Fentanyl - Normal Saline	Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
DRUG	Ropivacaine-Fentanyl-Normal Saline	Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
DRUG	Levobupivacaine- Fentanyl- Normal Saline	Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
DRUG	Bupivacaine + Fentanyl	Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
DRUG	Ropivacaine + Fentanyl	Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
DRUG	Levobupivacaine + Fentanyl	Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-03-20
• Last updated: 2012-04-27

Locations

1 site across 1 country: Greece