A comparative evaluation of intrathecal hyperbaric levobupivacaine 0.5% with hyperbaric bupivacaine 0.5% for elective cesarean section : A prospective randomised study.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- A COMPARATIVE EVALUATION OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE 0.5% WITH HYPERBARIC BUPIVACAINE 0.5% FOR ELECTIVE CESAREAN SECTION
Study Overview
Brief Summary
Spinal Anesthesia is accepted as a safe technique for cesarean section worldwide. With the increasing number of cesarean section under spinal anesthesia various local anesthetic agents are being studied for their efficacy, hemodynamic stability and other effects . Hyperbaric bupivacaine is most commonly used local anesthetic agent in elective cesarean section.
Bupivacaine is racemic mixture of dextro and levo and provides dense sensory and motor block which may lead to prolonged immobilization and hypotension.
Enantiomers may have the same desired pharmacological properties but fewer side effects. Levobupivacaine , the s enantiomer has shown to provide a more selective neuraxial blockade than racemic bupivacaine.
Hyperbaric levobupivacaine was commercially not available previously but as of now, hyperbaric solutions are available in India . The claimed benifits of these agents have reduced cardiac toxicity and more specific effects on sensory rather than motor nerve fibers . The decreased toxicity of levobupivacaine is attributed to it faster binding rate.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Pregnant Females between age 18 to 40 years.
- •Patients belonging to ASA grade 1 and
- •Subjects willing to sign informed consent for participation in study.
Exclusion Criteria
- •Patients under going caesearian section for fetal distress and hypertensive disorders of pregnancy.
- •Known allergy to the study drug
- •History of Liver, Renal & Cardiac diseases.
- •BMI > 30 5.Height <150cm and >180cm.
Outcomes
Primary Outcomes
A COMPARATIVE EVALUATION OF INTRATHECAL HYPERBARIC LEVOBUPIVACAINE 0.5% WITH HYPERBARIC BUPIVACAINE 0.5% FOR ELECTIVE CESAREAN SECTION
Time Frame: 1.ONSET OF SENSORY BLOCK | 2.MAXIMUM HEIGHT OF SENSORY BLOCK | 3.DURATION OF SENSORY BLOCK | 4.ONSET OF MOTOR BLOCK | 5.DURATION OF MOTOR BLOCK
Secondary Outcomes
- Hemodynamic parameters (Heart Rate and Mean Arterial Pressure).(Side effects like nausea, vomiting, bradycardia and Hypotension.)