Cesarean Section Clinical Trial
Official title:
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension
Background: Poor spinal anaesthesia block is common and is difficult to manage; so a
technique to minimize its incidence is advisable. Hypotension is the commonest problem with
spinal anesthesia. Multiple trials to prevent or combat hypotension using positional
changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and
mode of administration as either bolus or infusion is still a matter of debate.
Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and
fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.
Design: A randomized, controlled clinical trial.
Setting: Single medical center from 5/2013 to 10/2014.
Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were
randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia
using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S
received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a
second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was
started as fast drip during, and continued after spinal anesthesia.
Patients were monitored for hemodynamic parameters, time of sensory onset and height of
maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and
the frequency of side effects.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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