Subarachnoid Administration of Levobupivacaine for Cesarean Section

This study is currently recruiting participants.
Verified April 2012 by University of Patras
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

April 14, 2012
April 19, 2012
January 2010
April 2012   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01582607 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Stillborn Caesarean Section
  • Drug: Bupivacaine plain
    2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
    Other Name: Marcaine Spinal 5 mg/ml, AstraZeneca
  • Drug: Ropivacaine plain
    2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
    Other Name: Naropeine 7.5mg/ml, AstraZeneca
  • Drug: Levobupivacaine plain
    2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
    Other Name: Chirocaine 5mg/ml, Abbott Laboratories
  • 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
  • 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
  • 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
  • Active Comparator: Group B
    subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%
    Intervention: Drug: Bupivacaine plain
  • Active Comparator: Group R
    subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%
    Intervention: Drug: Ropivacaine plain
  • Active Comparator: Group LB
    subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%
    Intervention: Drug: Levobupivacaine plain
  • Active Comparator: Group RF
    subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl
    Intervention: Drug: ropivacaine plain +. fentanyl
  • Active Comparator: Group BF
    subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
    Intervention: Drug: bupivacaine plain +fentanyl
  • Active Comparator: Group LBF
    subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
    Intervention: Drug: Levobupivacaine plain +fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
May 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact: Kriton S Filos, Professor 2610999341 ext 0030 kritonfilos@yahoo.gr
Greece
 
NCT01582607
3089
Yes
Nikolaos G. Flaris, University of Patras
University of Patras
Not Provided
Principal Investigator: Nikolaos G Flaris, MD University Hospital of Patras
Study Director: Kriton S Filos, Professor University Hospital of Patras
University of Patras
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP