Subarachnoid Administration of Levobupivacaine for Cesarean Section

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

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.

Study Overview

• Status: Unknown
• Conditions: Stillborn Caesarean Section
• Intervention / Treatment: Drug: Bupivacaine plain; Drug: Ropivacaine plain; Drug: Levobupivacaine plain; Drug: ropivacaine plain +. fentanyl; Drug: bupivacaine plain +fentanyl; Drug: Levobupivacaine plain +fentanyl

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece, 26504
      • Recruiting
      • University Hospital of Patras, Department of Anesthesiology
      • Contact: Kriton S Filos, Professor; Phone Number: +302610999341; Email: kritonfilos@yahoo.gr
      • Contact: Nikolaos G Flaris, MD; Phone Number: +306936622601; Email: nflaris@yahoo.gr
      • Principal Investigator: Nikolaos G Flaris, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group B; subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%	Drug: Bupivacaine plain; 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally; Other Names: Marcaine Spinal 5 mg/ml, AstraZeneca
Active Comparator: Group R; subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%	Drug: Ropivacaine plain; 2.0 ml (15mg) plain ropivacaine 0.75% intrathecally; Other Names: Naropeine 7.5mg/ml, AstraZeneca
Active Comparator: Group LB; subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%	Drug: Levobupivacaine plain; 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally; Other Names: Chirocaine 5mg/ml, Abbott Laboratories
Active Comparator: Group RF; subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl	Drug: ropivacaine plain +. fentanyl; 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally; Other Names: Naropeine 7.5mg/ml, AstraZeneca; Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Active Comparator: Group BF; subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl	Drug: bupivacaine plain +fentanyl; 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally; Other Names: Marcaine Spinal 5 mg/ml; Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Active Comparator: Group LBF; subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl	Drug: Levobupivacaine plain +fentanyl; 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally; Other Names: Fentanyl, 50μg/ml, Janssen-Cilag, Belgium; Chirocaine 5mg/ml, Abbott laboratories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory block	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)	up to 150 minutes average
Motor block	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)	up to 150 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamics profile (arterial pressure. heart rate)	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)	up to 150 minutes average

Collaborators and Investigators

• Sponsor: University of Patras
• Investigators: Principal Investigator: Nikolaos G Flaris, MD, University Hospital of Patras; Study Director: Kriton S Filos, Professor, University Hospital of Patras

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: April 14, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: 3089