search
Back to results

Subarachnoid Administration of Levobupivacaine for Cesarean Section

Primary Purpose

Stillborn Caesarean Section

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Bupivacaine plain
Ropivacaine plain
Levobupivacaine plain
bupivacaine plain +fentanyl
ropivacaine plain +. fentanyl
Levobupivacaine plain +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

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of Patras, Department of AnesthesiologyRecruiting

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 B

Group R

Group LB

Group RF

Group BF

Group LBF

Arm Description

subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%

subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%

subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%

subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl

subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl

subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl

Outcomes

Primary Outcome Measures

Sensory block
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
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)
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)

Full Information

First Posted
April 14, 2012
Last Updated
April 19, 2012
Sponsor
University of Patras
search

1. Study Identification

Unique Protocol Identification Number
NCT01582607
Brief Title
Subarachnoid Administration of Levobupivacaine for Cesarean Section
Official Title
Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective 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
April 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Active Comparator
Arm Description
subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%
Arm Title
Group R
Arm Type
Active Comparator
Arm Description
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%
Arm Title
Group LB
Arm Type
Active Comparator
Arm Description
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%
Arm Title
Group RF
Arm Type
Active Comparator
Arm Description
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl
Arm Title
Group BF
Arm Type
Active Comparator
Arm Description
subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
Arm Title
Group LBF
Arm Type
Active Comparator
Arm Description
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
Intervention Type
Drug
Intervention Name(s)
Bupivacaine plain
Other Intervention Name(s)
Marcaine Spinal 5 mg/ml, AstraZeneca
Intervention Description
2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
Intervention Type
Drug
Intervention Name(s)
Ropivacaine plain
Other Intervention Name(s)
Naropeine 7.5mg/ml, AstraZeneca
Intervention Description
2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine plain
Other Intervention Name(s)
Chirocaine 5mg/ml, Abbott Laboratories
Intervention Description
2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
Intervention Type
Drug
Intervention Name(s)
bupivacaine plain +fentanyl
Other Intervention Name(s)
Marcaine Spinal 5 mg/ml, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Intervention Description
2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
Intervention Type
Drug
Intervention Name(s)
ropivacaine plain +. fentanyl
Other Intervention Name(s)
Naropeine 7.5mg/ml, AstraZeneca, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Intervention Description
2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine plain +fentanyl
Other Intervention Name(s)
Chirocaine 5mg/ml, Abbott laboratories, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Intervention Description
2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
Primary Outcome Measure Information:
Title
Sensory block
Description
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)
Time Frame
up to 150 minutes average
Title
Motor block
Description
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)
Time Frame
up to 150 minutes
Secondary Outcome Measure Information:
Title
Hemodynamics profile (arterial pressure. heart rate)
Description
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)
Time Frame
up to 150 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kriton S Filos, Professor
Phone
2610999341
Ext
0030
Email
kritonfilos@yahoo.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos G Flaris, MD
Organizational Affiliation
University Hospital of Patras
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kriton S Filos, Professor
Organizational Affiliation
University Hospital of Patras
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Patras, Department of Anesthesiology
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
+302610999341
Email
kritonfilos@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Nikolaos G Flaris, MD
Phone
+306936622601
Email
nflaris@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Nikolaos G Flaris, MD

12. IPD Sharing Statement

Learn more about this trial

Subarachnoid Administration of Levobupivacaine for Cesarean Section

We'll reach out to this number within 24 hrs