NCT01558713

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.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

March 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

2.7 years

First QC Date

March 14, 2012

Last Update Submit

April 26, 2012

Conditions

Stillborn Caesarean Section

Keywords

parturient

Outcome Measures

Primary Outcomes (2)

  • 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

    up to 120 minutes average

  • 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

    up to 120 minutes average

Secondary Outcomes (1)

  • Arterial Blood Pressure

    up to 120 minutes average

Study Arms (6)

Group BFS

ACTIVE COMPARATOR

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

Group RFS

ACTIVE COMPARATOR

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

Group LFS

ACTIVE COMPARATOR

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

BupivacaineF

ACTIVE COMPARATOR

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

Drug: Bupivacaine + Fentanyl

RopivacaineF

ACTIVE COMPARATOR

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

Drug: Ropivacaine + Fentanyl

LevobupivacaineF

ACTIVE COMPARATOR

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

Drug: Levobupivacaine + Fentanyl

Interventions

Bupivacaine- Fentanyl - Normal SalineDRUG

Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus

Also known as: 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
Group BFS
Ropivacaine-Fentanyl-Normal SalineDRUG

Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus

Also known as: Ropivacaine 0.75% :( Naropeine 7.5mg/ml, AstraZeneca), Fentanyl: 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Group RFS
Levobupivacaine- Fentanyl- Normal SalineDRUG

Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus

Also known as: Chirocaine 5mg/ml, Abbot Laboratories, Greece, Fentanyl, 50μg/ml, Janssen-Cilag, Belgium, 0,9% Sodium Chloride Inj. BP, B.Braun Melsungen AG
Group LFS
Bupivacaine + FentanylDRUG

Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus

Also known as: Bupivacaine hydrochloride 0,5% (Marcaine Spinal, 5mg/ml,AstraZeneca,Missisipi, ON, Canada), Fentanyl, 50μg/ml (Janssen-Cilag, Belgium)
BupivacaineF
Ropivacaine + FentanylDRUG

Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.

Also known as: Ropivacaine 0,75% :(Naropeine 7,5mg/ml, AstraZeneca), Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
RopivacaineF
Levobupivacaine + FentanylDRUG

Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus

Also known as: Chirocaine 5mg/ml, Abbot Laboratories, Greece., Fentanyl 50μg/ml, Janssen-Cilag, Belgium.
LevobupivacaineF

Eligibility Criteria

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

You may qualify if:

  • Elective cesarean section
  • ASA I-II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

MeSH Terms

Interventions

BupivacaineFentanylRopivacaineLevobupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • KRITON S FILOS, PROFESSOR

    Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras

    STUDY CHAIR

  • Christina G Sklavou, MD

    Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KRITON S FILOS, PROFESSOR

CONTACT

+302613603341kritonfilos@yahoo.gr

CHRISTINA G SKLAVOU, MD

CONTACT

+302613603346sklavou.christina@yahoo.gr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, 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

March 14, 2012

First Posted

March 20, 2012

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

GR(1)