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Subarachnoid Administration of Levobupivacaine for Cesarean Section

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Patras.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nikolaos G. Flaris, University of Patras
ClinicalTrials.gov Identifier:
NCT01582607
First received: April 14, 2012
Last updated: April 19, 2012
Last verified: April 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Fentanyl
Levobupivacaine
Ropivacaine
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014