search
Back to results

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

Primary Purpose

Stillborn Caesarean Section

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Bupivacaine- Fentanyl - Normal Saline
Ropivacaine-Fentanyl-Normal Saline
Levobupivacaine- Fentanyl- Normal Saline
Bupivacaine + Fentanyl
Ropivacaine + Fentanyl
Levobupivacaine + Fentanyl
Sponsored by
University of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stillborn Caesarean Section focused on measuring parturient

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anesthesiology and Intensive Care Medicine, University Hospital of PatrasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group BFS

Group RFS

Group LFS

BupivacaineF

RopivacaineF

LevobupivacaineF

Arm Description

Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%

Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%

Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%

Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY

Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.

Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.

Outcomes

Primary Outcome Measures

Dermatomes of Sensory block
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
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
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

Full Information

First Posted
March 14, 2012
Last Updated
April 26, 2012
Sponsor
University of Patras
search

1. Study Identification

Unique Protocol Identification Number
NCT01558713
Brief Title
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Patras

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stillborn Caesarean Section
Keywords
parturient

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group BFS
Arm Type
Active Comparator
Arm Description
Group B: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
Arm Title
Group RFS
Arm Type
Active Comparator
Arm Description
Group R : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
Arm Title
Group LFS
Arm Type
Active Comparator
Arm Description
Group L: LEVO-BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY, FOLLOWED BY EPIDURAL ADMINISTRATION OF 10 ml N/S 0,9%
Arm Title
BupivacaineF
Arm Type
Active Comparator
Arm Description
Group BupivacaineF: BUPIVACAINE 0,5% 2ml + 10μg FENTANYL(0,2ml) INTRATHECALLY
Arm Title
RopivacaineF
Arm Type
Active Comparator
Arm Description
Group RopivacaineF : ROPIVACAINE 0,75% 2ml + 10μg FENTANYL ( 0,2ml) INTRATHECALLY.
Arm Title
LevobupivacaineF
Arm Type
Active Comparator
Arm Description
Group LevobupivacaineF: LEVO-BUPIVACAINE 0,5% (2ml) + 10μg FENTANYL(0,2ml) INTRATHECALLY.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine- Fentanyl - Normal Saline
Other Intervention Name(s)
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
Intervention Description
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Intervention Type
Drug
Intervention Name(s)
Ropivacaine-Fentanyl-Normal Saline
Other Intervention Name(s)
Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca), Fentanyl: 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Intervention Description
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine- Fentanyl- Normal Saline
Other Intervention Name(s)
Chirocaine 5mg/ml, Abbot Laboratories, Greece, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Intervention Description
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
Intervention Type
Drug
Intervention Name(s)
Bupivacaine + Fentanyl
Other Intervention Name(s)
Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada), Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)
Intervention Description
Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Intervention Type
Drug
Intervention Name(s)
Ropivacaine + Fentanyl
Other Intervention Name(s)
Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca), Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
Intervention Description
Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine + Fentanyl
Other Intervention Name(s)
Chirocaine 5mg/ml, Abbot Laboratories, Greece., Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
Intervention Description
Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
Primary Outcome Measure Information:
Title
Dermatomes of Sensory block
Description
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
Time Frame
up to 120 minutes average
Title
Motor block
Description
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
Time Frame
up to 120 minutes average
Secondary Outcome Measure Information:
Title
Arterial Blood Pressure
Description
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
Time Frame
up to 120 minutes average

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KRITON S FILOS, PROFESSOR
Phone
+302613603341
Ext
+30
Email
kritonfilos@yahoo.gr
First Name & Middle Initial & Last Name or Official Title & Degree
CHRISTINA G SKLAVOU, MD
Phone
+302613603346
Email
sklavou.christina@yahoo.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KRITON S FILOS, PROFESSOR
Organizational Affiliation
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christina G Sklavou, MD
Organizational Affiliation
Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras
City
Patras
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KRITON S FILOS, PROFESSOR
Phone
+302613603342
Ext
+30
Email
kritonfilos@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Christina G Sklavou, MD
Phone
+306974337046
Ext
+30
Email
sklavou.christina@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Christina G Sklavou, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs