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
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
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
Start Date: January 2010
Completed Date: May 2012
Phase: Phase 2/Phase 3
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