Subarachnoid Administration of Levobupivacaine for Cesarean Section - Full Text View

Purpose

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.

Condition	Intervention	Phase
Stillborn Caesarean Section	Drug: Bupivacaine plain Drug: Ropivacaine plain Drug: Levobupivacaine plain Drug: bupivacaine plain +fentanyl Drug: ropivacaine plain +. fentanyl Drug: Levobupivacaine plain +fentanyl	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Fentanyl Fentanyl citrate Bupivacaine hydrochloride Bupivacaine Ropivacaine monohydrochloride

U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:

Sensory block [ Time Frame: up to 150 minutes average ] [ Designated as safety issue: Yes ]
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 [ Time Frame: up to 150 minutes ] [ Designated as safety issue: Yes ]
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:

Hemodynamics profile (arterial pressure. heart rate) [ Time Frame: up to 150 minutes average ] [ Designated as safety issue: Yes ]
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)

Estimated Enrollment:	130
Study Start Date:	January 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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: Chirocaine 5mg/ml, Abbott laboratories Fentanyl, 50μg/ml, Janssen-Cilag, Belgium

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582607

Contacts

Contact: Kriton S Filos, Professor

2610999341 ext 0030

kritonfilos@yahoo.gr

Locations

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

Sponsors and Collaborators

University of Patras

Investigators

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

More Information

No publications provided

Responsible Party:	Nikolaos G. Flaris, Anesthesiologist,MD, University of Patras
ClinicalTrials.gov Identifier:	NCT01582607 History of Changes
Other Study ID Numbers:	3089
Study First Received:	April 14, 2012
Last Updated:	April 19, 2012
Health Authority:	Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:

Bupivacaine
Ropivacaine
Levobupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 17, 2013