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Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections

This study is currently recruiting participants.
Verified April 2012 by University of Patras
Sponsor:
Information provided by (Responsible Party):
SKLAVOU CHRISTINA, University of Patras
ClinicalTrials.gov Identifier:
NCT01558713
First received: March 14, 2012
Last updated: April 26, 2012
Last verified: April 2012
History of Changes

March 14, 2012
April 26, 2012
January 2010
September 2012   (final data collection date for primary outcome measure)
  • Dermatomes of Sensory block [ Time Frame: up to 120 minutes average ] [ Designated as safety issue: Yes ]
    Dermatomes of sensory block(pin prick test) are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal of sensory block
  • Motor block [ Time Frame: up to 120 minutes average ] [ Designated as safety issue: Yes ]
    Motor block according to the Bromage scale are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal motor block
Dermotomes of Sensory block and Motor block (Bromage Scale) [ Time Frame: up to 120 minutes average ] [ Designated as safety issue: Yes ]
Dermotomes of sensory block and motor block according to the Bromage scale are assessed every minute for the first 30 minutes after the intrathecal administration of local anesthetics and there after every 5 minutes until withdrawal of sensory and motor block
Complete list of historical versions of study NCT01558713 on ClinicalTrials.gov Archive Site
Arterial Blood Pressure [ Time Frame: up to 120 minutes average ] [ Designated as safety issue: Yes ]
Measurements assesed every minute within the first 30 minutes after the intrathecal administration of local anesthetics and every 5 minutes until withdrawal of sensory and motor block
Same as current
Not Provided
Not Provided
 
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
Assessment of Sensory and Motor Block After Intrathecal Administration of Bupivacaine, Ropivacaine and Levo-bupivacaine Combined With Small Doses of Fentanyl, Followed by Administration of Normal Saline Epidurally:a Clinical Trial in Parturients Scheduled for C-section

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.

Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Stillborn Caesarean Section
  • Drug: Bupivacaine- Fentanyl - Normal Saline
    Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
    Other Names:
    • Bupivacaine hydrochloride 0.5% ( Marcaine Spinal, 5 mg/ml, AstraZeneca, Missisipi, ON, Canada)
    • Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
    • 0,9% Sodium Chloride Inj. BP, B.BRAUN Melsungen AG, German
  • Drug: Ropivacaine-Fentanyl-Normal Saline
    Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
    Other Names:
    • Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca)
    • Fentanyl: 50μg/ml, Janssen-Cilag, Belgium
    • 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
  • Drug: Levobupivacaine- Fentanyl- Normal Saline
    Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
    Other Names:
    • Chirocaine 5mg/ml, Abbot Laboratories, Greece
    • Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
    • 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
  • Drug: Bupivacaine + Fentanyl
    Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
    Other Names:
    • Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada)
    • Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)
  • Drug: Ropivacaine + Fentanyl
    Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
    Other Names:
    • Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca)
    • Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
  • Drug: Levobupivacaine + Fentanyl
    Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
    Other Names:
    • Chirocaine 5mg/ml, Abbot Laboratories, Greece.
    • Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
  • Active Comparator: Group BFS
    Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
    Intervention: Drug: Bupivacaine- Fentanyl - Normal Saline
  • Active Comparator: Group RFS
    Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
    Intervention: Drug: Ropivacaine-Fentanyl-Normal Saline
  • Active Comparator: Group LFS
    Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
    Intervention: Drug: Levobupivacaine- Fentanyl- Normal Saline
  • Active Comparator: BupivacaineF
    Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY
    Intervention: Drug: Bupivacaine + Fentanyl
  • Active Comparator: RopivacaineF
    Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.
    Intervention: Drug: Ropivacaine + Fentanyl
  • Active Comparator: LevobupivacaineF
    Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
    Intervention: Drug: Levobupivacaine + Fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective cesarean section
  • ASA I-II

Exclusion Criteria:

  • complicated pregnancy (i.e preeclampsia, eclampsia,arterial hypertension, diabetes mellitus)
  • abnormal fetal heart rate at the time of admission
  • body mass index > 35 kg/m2
  • height <150cm and >185 cm
  • age <18 yrs and >40 yrs
  • patients with contraindication to spinal anaesthesia( i.e anticoagulants)
  • ASA >III
  • intraoperative excessive bleeding
  • patients with previous psychiatric diseases
Female
18 Years to 40 Years
Yes
Contact: KRITON S FILOS, PROFESSOR +302613603341 ext +30 kritonfilos@yahoo.gr
Contact: CHRISTINA G SKLAVOU, MD +302613603346 sklavou.christina@yahoo.gr
Greece
 
NCT01558713
1312010-25
No
SKLAVOU CHRISTINA, University of Patras
University of Patras
Not Provided
Study Chair: KRITON S FILOS, PROFESSOR Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Principal Investigator: Christina G Sklavou, MD Department of Anesthesia and Intensive Care Medicine, 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