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

NCT01558713 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-04-27

No results posted yet for this study

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.

Conditions

  • Stillborn Caesarean Section

Interventions

DRUG

Bupivacaine- Fentanyl - Normal Saline

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

DRUG

Ropivacaine-Fentanyl-Normal Saline

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

DRUG

Levobupivacaine- Fentanyl- Normal Saline

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

DRUG

Bupivacaine + Fentanyl

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

DRUG

Ropivacaine + Fentanyl

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

DRUG

Levobupivacaine + Fentanyl

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

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • KRITON S FILOS, PROFESSOR · Department of Anesthesiology and Intensive Care Medicine, University Hospital of Patras

  • Christina G Sklavou, MD · Department of Anesthesia and Intensive Care Medicine, University Hospital of Patras

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-09-30
Completion
2012-12-31

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 NCT01558713 on ClinicalTrials.gov