Efficacy of Different Doses of Fentanyl With Intrathecal Low Dose Levobupivacaine on Recovery profile in cesarean section A Prospective Randomized Double Blind Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Time for complete recovery from Motor block After giving spinal anaesthesia
Study Overview
Brief Summary
The aim of study is to evaluate the effect of different doses of fentanyl with low dose levobupivacaine on recovery profile in cesarean section.
284 Pregnant women will be divided into three groups, In each group there will be 95 patient come who are posted for elective cesarean section.
In group LF 10 , 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 10 microgram(0.2 ml) + 0.3 ml Normal saline, Total 2.0 ml drug given.
In group LF 15, 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 15 microgram(0.3 ml)+ 0.2 ml Normal saline, Total 2.0 ml drug given.
In group LF 20, 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 20 microgram(0.4 ml)+ 0.2 ml Normal saline, Total 2.0 ml drug given.
Time for complete recovery from Motor block as primary outcome.
As secondary outcome two segment regression time, time for complete recovery from sensory block( Duration of sensory block), Time to achieve T4-T6, Duration of Analgesia, patient satisfaction score, hemodynamic parameters, apgar score in newborn, any side effects like nausea, vomiting, hypotension, tachycardia/ bradycardia, respiratory depression, pruritus, high spinal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •ASA Grade II patients planned for cesarean section under spinal anaesthesia.
- •Able to understand study procedure and given consent.
Exclusion Criteria
- •Refusal to take part in study
- •Coagulopathy/ Sickle cell disease/ Diabetes Mellitus/ Hypertensive Disorder/ Eclampsia/ Anaemia
- •Allergy or Contraindication to study drugs
- •Pre-mature rupture of membrane, bleeding P/V, uterine abnormality.
Outcomes
Primary Outcomes
Time for complete recovery from Motor block After giving spinal anaesthesia
Time Frame: from zero minute after giving spinal anaesthesia
Secondary Outcomes
- 1. Two segment regression time(2. Time for Complete recovery from sensory block (Duration of sensory block))
Investigators
Dr Hemangini Patel
Government medical college, Baroda