Text Size

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
  Purpose

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.


Condition Intervention Phase
Stillborn Caesarean Section
 Drug: Bupivacaine- Fentanyl - Normal Saline
Drug: Ropivacaine-Fentanyl-Normal Saline
Drug: Levobupivacaine- Fentanyl- Normal Saline
Drug: Bupivacaine + Fentanyl
Drug: Ropivacaine + Fentanyl
Drug: Levobupivacaine + Fentanyl
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%
 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
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%
 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
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%
 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
Active Comparator: BupivacaineF
Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY
 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)
Active Comparator: RopivacaineF
Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.
 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.
Active Comparator: LevobupivacaineF
Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
 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.

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558713

Contacts
Contact: KRITON S FILOS, PROFESSOR +302613603341 ext +30 kritonfilos@yahoo.gr
Contact: CHRISTINA G SKLAVOU, MD +302613603346 sklavou.christina@yahoo.gr

Locations
Greece
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras Recruiting
Patras, Achaia, Greece, 26504
Contact: KRITON S FILOS, PROFESSOR     +302613603342 ext +30     kritonfilos@yahoo.gr    
Contact: Christina G Sklavou, MD     +306974337046 ext +30     sklavou.christina@yahoo.gr    
Principal Investigator: Christina G Sklavou, MD            
Sponsors and Collaborators
University of Patras
Investigators
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
  More Information

No publications provided

Responsible Party: SKLAVOU CHRISTINA, Anesthesiologist- MD, University of Patras
ClinicalTrials.gov Identifier: NCT01558713     History of Changes
Other Study ID Numbers: 1312010-25
Study First Received: March 14, 2012
Last Updated: April 26, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
parturient

Additional relevant MeSH terms:
Anesthetics, Local
Bupivacaine
Ropivacaine
Levobupivacaine
Fentanyl
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 May 23, 2013