Erector Spinae Plane Block: To study the effect of Dexmeditomidine as an adjuvant to 0.375% Ropivacaine on quality & duration of Erector Spinae Plane Block in Lumbar Spine Surgeries, a randomized control trial study

Aims and Objective Primary 1.     To observe & evaluate efficacy & duration of analgesia. 2.     Total duration of analgesia. Total duration of analgesia will be calculated as requirement of first analgesic dose after the block. Secondary 2. To evaluate the effects of Dexmeditomidine as an adjuvant  A)  Hemodynamic parameters.    B)   Sedation.  C)   Adverse effect, if any. Materials & Methods: Study Type : Prospective Randomized Control Trial study This will be a Prospective randomized control trial done in Department of Anaesthesia in collaboration with Orthopedic department Rural medical college, Loni. In this study we will evaluate the efficacy of Dexmeditomidine as an adjuvant to Ropivacaine in Erector Spinae Plane Block. In this study, patients undergoing posterior lumbar surgeries, will be recruited & randomly divided into two groups, intervention & control. Inclusion criteria Ø Age : 18 yrs & above Ø Physical Status : ASA Grade 1-11   Surgeries : Elective one or two level posterior lumbar decompression,  discectomies, interbody fusion Exclusion criteria Contraindication to regional blocks : coagulopathy & infection at the block site. History of  opioid abuse. Physical status – more than ASA11. History of allergy to any trial drugs, such as Local Anaesthetics & NSAIDS. Any other condition that precluded study inclusion Patient Refusal Study conduct: All patients will be examined and assessed pre-operatively for anaesthetic fitness with respect to ASA grading I -11 . Routine investigations will be done. Nature of anaesthesia to be given will be explained to the patients and a valid, written consent will be obtained from the patients. Patients will be kept Nil By Mouth for 6 hours before surgery but clear fluids will be allowed up to 2 hours before commencement of anaesthesia.. Group allocation: The patients will be randomly allocated to 1 of the two groups according to the study drug. Simple Random sampling with Lottery Method will be used for allocation.  Group I (control): Patient will receive 40 ml 0.375% Ropivacaine with 0.01ml/kg NS for ESPB, bilaterally  Group II (Case) : Patients will receive 0.375% Ropivacaine with 1mcg/kg ( 0.01ml/kg) Dexmeditomidine in a total 40 ml for Erector Spinae plane blocks, bilaterally Technique: In the operation room, intravenous infusion with Ringers Lactate will be started, Oxygen given through facemask 3 litter/minute and routine monitoring as SpO2, NIBP and ECG will be  applied (Philips MP 50). Before starting the procedure pulse rate, blood pressure, respiratory rate and oxygen saturation will be recorded. Patient will be given general anaesthesia as per institutional protocol. After giving prone position to the patient, Ultrasound guided Erector Spinae Plane Block will be performed bilaterally.  Close monitoring of pulse rate and blood pressure will be done throughout the procedure. We considered fall in systolic blood pressure more than 20% of baseline as a hypotension. Similarly fall in heart rate more than 20% of baseline will be considered as bradycardia. The intra operative hemodynamic monitoring is done at an interval of 15 minutes.  Requirement of opioids & top up doses of neuromuscular blocking drugs, are noted. The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours, then at 2,3,4,6,8,12,16,20 & 24 hours respectively with Visual Analog Score ( VAS) pain scores, after surgery, at rest &  with movement. Other end points included will be Opioid consumption, other analgesic preparations required.