Post Operative Pain Clinical Trial
Objective :To compare the analgesic effect of intrathecal clonidine and fentanyl as an
additive to bupivacaine in patients undergoing cesarean section .
Methods:Following Ethics Committee approval and informed patients consent, Ninety patients
18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal
anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were
randomly allocated to one of three groups of 30 each. The clonidine group (groupC) received
bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group
(group F) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group
(group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time
to first requirement of analgesic supplement, Sensory block onset time, maximum sensory
level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of
hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen
(SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation,
dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were
instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no
pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the
patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for
post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of
administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
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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