Stillborn Caesarean Section Clinical Trial
Official title:
Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | May 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Patras, Department of Anesthesiology | Patras | Achaia |
Lead Sponsor | Collaborator |
---|---|
University of Patras |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensory block | sensory block (pin prick test): every 1 min until 30min, every 5 min until 60min. every 10 min until regression to O1 (average 150 minutes) | up to 150 minutes average | Yes |
Primary | Motor block | Motor block (Bromage scale): every 1 min until 30min, every 5 min until 60min. every 10 min until complete recovery of motor function (average 150 minutes) | up to 150 minutes | Yes |
Secondary | Hemodynamics profile (arterial pressure. heart rate) | Measurement of arterial pressure and heart rate every 1 min for the first 30 min, every 5 min until 60 min, every 10 min until regression of sensory or motor block(average 150 minutes) | up to 150 minutes average | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01558713 -
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
|
Phase 2/Phase 3 |