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Subarachnoid Administration of Levobupivacaine for Cesarean Section

NCT01582607 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2012-04-20

No results posted yet for this study

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.

Conditions

  • Stillborn Caesarean Section

Interventions

DRUG

Bupivacaine plain

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

DRUG

Ropivacaine plain

2.0 ml (15mg) plain ropivacaine 0.75% intrathecally

DRUG

Levobupivacaine plain

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

DRUG

bupivacaine plain +fentanyl

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

DRUG

ropivacaine plain +. fentanyl

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

DRUG

Levobupivacaine plain +fentanyl

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

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • Nikolaos G Flaris, MD · University Hospital of Patras

  • Kriton S Filos, Professor · University Hospital of Patras

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582607 on ClinicalTrials.gov