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CTRI Number  CTRI/2024/05/067061 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing duration of postoperative analgesia using Inj.0.25% Bupivacaine with 8mg Dexamethasone versus Inj.0.375% Bupivacaine with 8mg Dexamethsone in USG guided Erector Spinae Plane Block performed in thoracolumbar spine surgeries. 
Scientific Title of Study   A Prospective, Randomised, Double blind study comparing postoperative analgesia using 0.25% Bupivacaine vs 0.375% Bupivacaine along with 8mg Dexamethasone in USG guided Erector Spinae Plane Block in thoracolumbar spine surgeries.  
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 Shrikanta Oak 
Designation  Professor (Additional) 
Affiliation  Seth G S Medical college and KEM Hospital, Mumbai  
Address  Department of Anaesthesia, First floor, Old building, KEM Hospital, Ernest Borges Marg, Parel 12

Mumbai
MAHARASHTRA
400066
India 
Phone  9324134023  
Fax    
Email  shrikanta_oak@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrikanta Oak 
Designation  Professor (Additional) 
Affiliation  Seth G S Medical college and KEM Hospital, Mumbai  
Address  Department of Anaesthesia, First floor, Old building, KEM Hospital, Ernest Borges Marg, Parel 12

Mumbai
MAHARASHTRA
400066
India 
Phone  9324134023  
Fax    
Email  shrikanta_oak@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Dhanshree S Thengadi 
Designation  Junior Resident in Dept Of Anaesthesia 
Affiliation  Seth G S Medical college and KEM Hospital, Mumbai  
Address  Department of Anaesthesia, First floor, Old building, KEM Hospital, Ernest Borges Marg, Parel 12

Mumbai
MAHARASHTRA
400066
India 
Phone  9403743024  
Fax    
Email  shreethengadi@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY SETH GS MEDICAL COLLEGE AND KEM HOSPITAL 
 
Primary Sponsor  
Name  SETH GS MEDICAL COLLEGE AND KEM HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SETH GSMC AND KEM HOSPITAL, ACHARYA DHONDE MARG, PAREL 12 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Shrikanta Oak  SETH GS MEDICAL COLLEGE AND KEM HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY, SETH GS MEDICAL COLLEGE AND KEM HOSPITAL, ACHARYA DHONDE MARG, PAREL 12
Mumbai
MAHARASHTRA 		 9324134023

shrikanta_oak@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(IEC)- I, RELATING TO BIOMEDICAL AND HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: G952||Other and unspecified cord compression,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.25% BUPIVACAINE WITH 0.375% BUPIVACAINE  24HOURS POSTOPERATIVE ANALGESIA COMPARED USING INJ.0.25% BUPIVACAINE WITH 8MG DEXAMETHASONE (15CC) VS O.375% BUPIVACAINE WITH 8MG DEXAMETHASONE (15CC) IN USG GUIDED ERECTOR SPINAE PLANE BLOCK GIVEN ONCE AFTER INDUCTION IN PRONE POSITION FOR THORACOLUMBAR SPINE SURGERIES, 
Intervention  USG GUIDED ERECTOR SPINAE PLANE BLOCK  USG GUIDED ERECTOR SPINAE INTERFASCIAL PLANE BLOCK FOR EVALUATING DURATION OF POSTOPERATIVE ANALGESIA IN THORACOLUMBAR SPINE SURGERIES. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -ASA grade I–II
-Planned posterior approach spinal surgery involving 2-3 levels of laminectomy in the lumbar or thoracic regions.
-Surgery with a maximum duration of 3 hours.
 
 
ExclusionCriteria 
Details  -Pregnant females
-Uncooperative patients with communication difficulties which might prevent a reliable post operative assessment.
-Relative contraindication like Pre-existing infection at block site, coagulopathy, allergy to local anaesthetics.
-Surgery involving 4 or more vertebral levels
-Revision surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluation of total duration of post operative Analgesia.   AT 2,4,6,10,14,18,24 HOURS. 
 
Secondary Outcome  
Outcome  TimePoints 
To note 1)Intraoperative hemodynamics. 2) Total consumption of rescue analgesia within 24hours 3) Complications like nausea vomiting, hypotension, hypertension, bradycardia, tachycardia.  24 HOURS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   17/05/2024 
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 Applicable 
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   Postoperative analgesia in patients undergoing thoraco lumbar spine surgery is challenging due to the invasiveness of the surgical procedure and the frequent use of opioids perioperatively by many patients. The Study Aims to compare the duration of postoperative analgesia in USG guided erector spinae plane block in thoracolumbar spine surgeries using 0.25% bupivacaine and 8mg Dexamethasone vs 0.375% bupivacaine and 8mg dexamethasone. 
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