Introduction: Spinal anaesthesia is routinely used for lower umblical procedures.Bupivacaine 0.5%heavy is routinely used .Recently levobupivacaine is introduced .it has more cardio stability.I BETWEEN n this study we are comparing spinal anaesthesia effect isobaric 0.5% Levobupivacaine and isobaric 0.5% Ropivacaine Aim: To compare the clinical effect and quality of spinal isobaric 0.5% Levobupivacaine and isobaric 0.5% Ropivacaine for elective open hernia surgeries Primary objective To compare the time of onset of sensory block, To compare the time to peak sensory block To observe the differences in the duration of sensory block To determine the duration of analgesia Secondary objective To observe and compare the hemodynamic instability To identify the complications developing if any CENTRE : Stanley medical college hospital, Chennai DURATION : 6 months DESIGN : A Randomised , Prospective study POPULATION : Patients coming for Elective open hernia surgeries SAMPLE SIZE : 50 Based on the reference study done by Samar et al, Mumbai Formula: n = 2 (Za+ZB)2 SD2 / (M1-M2)2 Where Za = 1.96 (statistical significant constant for 95% CI) , ZB = 0.84 (80% power) Sd = 1.82 (Standard deviation of onset of sensory block in minutes among patients belonging to levobupivacaine group from previous study. ) M1 =8.47 (Mean onset of sensory block in minutes among patients belonging to ropivacaine group from previous study.M2 = 6.97 (Mean onset of sensory block in minutes among patients belonging to levobupivacaine group from previous study.) (M1-M2)2 = 2.25 (1.5 x 1.5)On substituting in the formula.n = 15.6 x 1.8 x 1.8 / 2.25 ;n = 22 Adding 10% non response rate (ie 10% of 22= 2)n = 24 (minimum sample size).Therefore Sample size n = 25 (1 group) n = 50 (2 groups). Methodology: After ethical committee clearance and getting informed written consent fifty patients will be equally divided into two groups INCLUSION CRITERIA • American society of anaesthesiologist physical status I & II Age between 20 – 60 years Posted for elective open hernia surgery Patients willing to participate EXCLUSION CRITERIA American society of anaesthesiologist physical status III & IV Coagulation Abnormalities Localised Infections Severe renal,hepatic,& cardiovascular diseases Patients not willing for spinal anaesthesia Group A: Contains 25 patients will receive spinal anaesthesia with 2.0 ml 0.5 % Levobupivacaine Group B: Contains 25 patients will receive spinal anaesthesia with 2.0 ml 0.5 % Ropivacaine Randomization will be done using computer generated random numbers and allocation will be done using sealed envelope technique. Intravenous line will be secured and crystalloids connected.standars monitors like pulse oximeter,Non invasive blood pressure and Electro cardio gram will be connected. Sub arachnoid block will be given using quincke needle at L3-4 level with patient in sitting position. Patient, investigator and statistician will be blinded to the study drug as drug will be prepared by an anaesthesiologists who is not involved in the study. Heart rate,systolic and diastolic blood pressure and saturation will be monitored every 3miutes for first 10minutes then every 15 minutes till the end of the surgery Sensory block – pin prick test, 24g hypodermic needle – every 3 minutes initial 15 minutes then every 20 minutes T10- L1 – surgical dermatome Time of onset, time to achieve peak sensory level, duration of analgesiaHypotension, bradycardia, vomiting, desaturation, difficulty in breathing – appropriately managed Level inadequate/ breakthrough pain / prolonged surgical time – GA given Statisytical analysis: descriptive analysis of the data will be done .mean and standard deviation will be compared using student t test for normally distributed continuous variable and chi square test for discrete variable |