Intrathecal Plain Bupivacaine, Ropivacaine and Levo-bupivacaine With or Without Fentanyl for Elective c Section.
Overview
- Phase
- Phase 2
- Intervention
- Bupivacaine plain
- Conditions
- Stillborn Caesarean Section
- Sponsor
- University of Patras
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Sensory block
- Last Updated
- 14 years ago
Overview
Brief 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.
Detailed Description
Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with or without addition of fentanyl for c-section do not exist to date . Parturients scheduled for elective caesarean section will be allocated to receive double-blindly i.t. isobaric bupivacaine 10 mg, ropivacaine 15mg , levobupivacaine 10mg or the same local anaesthetics with 10 μg fentanyl respectively. Sensory block (pin prick test) and motor block (Bromage scale) profile, intraoperative and postoperative analgesia, haemodynamics and side effects will be assessed.
Investigators
Nikolaos G. Flaris
Anesthesiologist,MD
University of Patras
Eligibility Criteria
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
Arms & Interventions
Group B
subarachnoid administration of 2.0 mL (10mg) plain bupivacaine hydrochloride 0.5%
Intervention: Bupivacaine plain
Group R
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75%
Intervention: Ropivacaine plain
Group LB
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5%
Intervention: Levobupivacaine plain
Group RF
subarachnoid administration of 2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl
Intervention: ropivacaine plain +. fentanyl
Group BF
subarachnoid administration of 2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
Intervention: bupivacaine plain +fentanyl
Group LBF
subarachnoid administration of 2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl
Intervention: Levobupivacaine plain +fentanyl
Outcomes
Primary Outcomes
Sensory block
Time Frame: up to 150 minutes average
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)
Motor block
Time Frame: up to 150 minutes
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)
Secondary Outcomes
- Hemodynamics profile (arterial pressure. heart rate)(up to 150 minutes average)