Subarachnoid Administration of Levobupivacaine for Cesarean Section

Phase 2

• Conditions: Stillborn Caesarean Section
• Interventions: Drug: ropivacaine plain +. fentanyl; Drug: Bupivacaine plain; Drug: Ropivacaine plain; Drug: Levobupivacaine plain; Drug: bupivacaine plain +fentanyl; Drug: Levobupivacaine plain +fentanyl

• Registration Number: NCT01582607
• Lead Sponsor: University of Patras

Brief 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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-14
• Study First Submitted QC: 2012-04-19
• Last Update Submitted: 2012-04-19
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Parturients scheduled for elective c section
• Stillborn
• Normal cardiotocogram

Exclusion Criteria

• BMI>35kg/m2
• Height <150cm or >185cm
• Age (<18, >40)
• ASA > II
• Multiple gestation
• Pregnancy complications (eclampsia, GDP, placenta previa, >2 previous c section)
• Contraindication to spinal anaesthesia
• Failure to educate the patient, language barrier
• Patient preferred GA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group RF	ropivacaine plain +. fentanyl	subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl
Group B	Bupivacaine plain	subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%
Group R	Ropivacaine plain	subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%
Group LB	Levobupivacaine plain	subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%
Group BF	bupivacaine plain +fentanyl	subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
Group LBF	Levobupivacaine plain +fentanyl	subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl

Primary Outcome Measures

Name	Time	Method
Sensory block	up to 150 minutes average	sensory block (pin prick test): every 1 min until 30min, every 5 min until 60min. every 10 min until regression to O1 (average 150 minutes)
Motor block	up to 150 minutes	Motor block (Bromage scale): every 1 min until 30min, every 5 min until 60min. every 10 min until complete recovery of motor function (average 150 minutes)

Secondary Outcome Measures

Name	Time	Method
Hemodynamics profile (arterial pressure. heart rate)	up to 150 minutes average	Measurement of arterial pressure and heart rate every 1 min for the first 30 min, every 5 min until 60 min, every 10 min until regression of sensory or motor block(average 150 minutes)

Trial Locations

Locations (1)

University Hospital of Patras, Department of Anesthesiology; 🇬🇷 Patras, Achaia, Greece