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Stillborn Caesarean Section | Subarachnoid Administration of Levobupivacaine for Cesarean Section

Stillborn Caesarean Section research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Stillborn Caesarean Section

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Bupivacaine plain2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally

Drug:Ropivacaine plain2.0 ml (15mg) plain ropivacaine 0.75% intrathecally

Drug:Levobupivacaine plain2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally

Drug:bupivacaine plain +fentanyl2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally

Drug:ropivacaine plain +. fentanyl2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally

Drug:Levobupivacaine plain +fentanyl2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

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

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

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

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

Study Status

Unknown status

Start Date: January 2010

Completed Date: May 2012

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Sensory block

Secondary Outcome: Hemodynamics profile (arterial pressure. heart rate)

Study sponsors, principal investigator, and references

Principal Investigator: Nikolaos G Flaris, MD

Lead Sponsor: University of Patras

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01582607

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