NCT01582607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

2.2 years

First QC Date

April 14, 2012

Last Update Submit

April 19, 2012

Conditions

Stillborn Caesarean Section

Outcome Measures

Primary Outcomes (2)

  • 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)

    up to 150 minutes average

  • 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)

    up to 150 minutes

Secondary Outcomes (1)

  • Hemodynamics profile (arterial pressure. heart rate)

    up to 150 minutes average

Study Arms (6)

Group B

ACTIVE COMPARATOR

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

Drug: Bupivacaine plain

Group R

ACTIVE COMPARATOR

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

Drug: Ropivacaine plain

Group LB

ACTIVE COMPARATOR

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

Drug: Levobupivacaine plain

Group RF

ACTIVE COMPARATOR

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

Drug: ropivacaine plain +. fentanyl

Group BF

ACTIVE COMPARATOR

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

Drug: bupivacaine plain +fentanyl

Group LBF

ACTIVE COMPARATOR

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

Drug: Levobupivacaine plain +fentanyl

Interventions

Bupivacaine plainDRUG

2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally

Also known as: Marcaine Spinal 5 mg/ml, AstraZeneca
Group B
Ropivacaine plainDRUG

2.0 ml (15mg) plain ropivacaine 0.75% intrathecally

Also known as: Naropeine 7.5mg/ml, AstraZeneca
Group R
Levobupivacaine plainDRUG

2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally

Also known as: Chirocaine 5mg/ml, Abbott Laboratories
Group LB
bupivacaine plain +fentanylDRUG

2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally

Also known as: Marcaine Spinal 5 mg/ml, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Group BF
ropivacaine plain +. fentanylDRUG

2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally

Also known as: Naropeine 7.5mg/ml, AstraZeneca, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Group RF
Levobupivacaine plain +fentanylDRUG

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

Also known as: Chirocaine 5mg/ml, Abbott laboratories, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium
Group LBF

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Parturients scheduled for elective c section
  • Stillborn
  • Normal cardiotocogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras, Department of Anesthesiology

Pátrai, Achaia, 26504, Greece

RECRUITING

MeSH Terms

Interventions

BupivacaineRopivacaineLevobupivacaineFentanyl

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nikolaos G Flaris, MD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

  • Kriton S Filos, Professor

    University Hospital of Patras

    STUDY DIRECTOR

Central Study Contacts

Kriton S Filos, Professor

CONTACT

2610999341kritonfilos@yahoo.gr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist,MD

Study Record Dates

First Submitted

April 14, 2012

First Posted

April 20, 2012

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

GR(1)