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CTRI Number  CTRI/2023/11/060314 [Registered on: 29/11/2023] Trial Registered Prospectively
Last Modified On: 24/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of Dexmeditomidine on quality & duration of Spinae Block in Spine Surgeries 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milind Pol 
Designation  Associate Professor 
Affiliation  Pravara Institute of medical Sciences 
Address  Department of Anesthesia
At Post Loni Bk Tal Rahata Dist Ahmednagar
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9890157520  
Fax  02422273442  
Email  drpolmilind@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Milind Pol 
Designation  Associate Professor 
Affiliation  Pravara Institute of medical Sciences 
Address  Department of Anesthesia
At Post Loni Bk Tal Rahata Dist Ahmednagar

MAHARASHTRA
413736
India 
Phone  9890157520  
Fax  02422273442  
Email  drpolmilind@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Milind Pol 
Designation  Associate Professor 
Affiliation  Pravara Institute of medical Sciences 
Address  Department of Anesthesia
At Post Loni Bk Tal Rahata Dist Ahmednagar

MAHARASHTRA
413736
India 
Phone  9890157520  
Fax  02422273442  
Email  drpolmilind@gmail.com  
 
Source of Monetary or Material Support  
Pravara Institute of Medical Sciences Loni 
 
Primary Sponsor  
Name  Pravara Institute of Medical Sciences 
Address  At Loni Bk Tal Rahata Dist Ahmednagar 
Type of Sponsor  Other [Deemed to be University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milind Pol  Pravara Institute of Medical Sciences  Deportment Of Anesthesia & Critical Care First Floor New OT Complex At Loni Bk Tal Rahata Dist Ahmednagar
Ahmadnagar
MAHARASHTRA 
9890157520
02422273442
drpolmilind@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee Pravara Institute of Medical Sciences Deeemed University IEC PIMS-DU Loni  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmeditomidine  Patients will receive 0.375% Ropivacaine with 1mcg/kg ( 0.01ml/kg) Dexmeditomidine in a total 40 ml for Erector Spinae plane blocks, bilaterally The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours The primary clinical outcome will be measured in post operative period at 30 minutes for first 2 hours 
Comparator Agent  NS  will receive 40 ml 0.375% Ropivacaine with 0.01ml/kg NS for ESPB, bilaterally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Physical Status : ASA Grade 1-11
Surgeries : Elective one or two level posterior lumbar decompression, discectomies, interbody fusion
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
observe & evaluate efficacy & duration of analgesia  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  
 
Secondary Outcome  
Outcome  TimePoints 
sedation
Adverse Events
SpO2, respiratory rate & evidence of respiratory distress  
All the patients will be observed for any side effects or complications in the post-operative period for 24 hours & following complications if occurred were noted & treated 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.
 
 
 
 
 

 
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