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CTRI Number  CTRI/2025/06/088680 [Registered on: 12/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two drugs for pain relief after spine surgery 
Scientific Title of Study   An Randomised Comparative Study to Compare the efficacy of Dexmedetomidine vs Dexamethasone as an adjuvant with Ropivacaine in Erector Spinae Block in Lumbar Spine Surgery under General Anaesthesia 
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 BINAY TEJA REDDY 
Designation  Resident Doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, SBKS Medical college, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  9182420631  
Fax    
Email  binayteja15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Jigisha Mehta 
Designation  Associate Professor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, SBKS Medical college, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  8866718168  
Fax    
Email  jbmehta.28@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR BINAY TEJA REDDY 
Designation  Resident Doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, SBKS Medical college, Waghodiya, Pipariya, Vadodara, Gujarat, 391760

Vadodara
GUJARAT
391760
India 
Phone  9182420631  
Fax    
Email  binayteja15@gmail.com  
 
Source of Monetary or Material Support  
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, waghodia, pipariya, Gujarat, 391760 
 
Primary Sponsor  
Name  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Wagodia, pipariya, Vadodara, Gujarat, 391760 
Type of Sponsor  Private 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 
D R Binay Teja Reddy  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department, General OT Complex, 2nd floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research centre, Waghodiya, Pipariya, Vadodara, Gujarat, 391760
Vadodara
GUJARAT 		 9182420631

binayteja15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone as an adjuvant with ropivacaine  The efficacy of dexamethasone 4mg as an adjuvant with ropivacaine0.375% in erector spinae block in lumbar spine surgery under general anaesthesia 
Intervention  Dexmedetomidine as an Adjuvant with Ropivacaine  The efficacy of dexmedetomidine 25mcg as an adjuvant with ropivacaine 0.375% in erector spinae block in lumbar spine surgery under general anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the study,
Patients of ASA grade I, II, III of either gender,
Patients undergoing elective lumbar surgery ,
Age of patients 18-75 years 
 
ExclusionCriteria 
Details  Patients refusal,
Patient belonging to ASA IV, V GRADE ,
Patients with bleeding and coagulation disorders,
Infection at the site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of dexmedetomidine with 0.375%ropivacaine vs dexamethasone with 0.375%ropivacaine in erector spinae block in lumbar spine surgery under general anaesthesia for intraoperative and postoperative pain management.  one hourly for next 24hours post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
The study focuses on assessing both intraoperative & postoperative pain control, comparing parameters such as duration of analgesia, total analgesic consumption, haemodynamic stability, & incidence of side effects.  hourly for next 24hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   01/07/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [binayteja15@gmail.com].

  6. For how long will this data be available start date provided 15-04-2025 and end date provided 15-11-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This randomised comparative study aims to evaluate the efficacy of dexmedetomidine versus dexamethasone as adjuvants to 0.375% ropivacaine in erector spinae plane (ESP) block for patients undergoing lumbar spine surgery under general anaesthesia. The study focuses on assessing both intraoperative and postoperative pain control, comparing parameters such as duration of analgesia, total analgesic consumption, haemodynamic stability, and incidence of side effects. By identifying the more effective adjuvant, this research seeks to enhance patient comfort and improve pain management strategies in lumbar spine surgeries. 
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