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CTRI Number  CTRI/2024/09/073267 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
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   Comparison of QL block with ropivacaine dexmedetomidine versus QL block with ropivacaine dexamethasone in lower abdominal gynecological procedure  
Scientific Title of Study   A Comparative study of Ropivacaine Dexmedetomidine and Ropivacaine Dexamethasone in Posterior Quadratus Lumborum block Lower abdominal gynecological Surgeries: A Double Blinded Randomised Control Trail  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geethesh M 
Designation  Post graduate  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  A6, Department of Anaesthesia and intensive care medicine Sri Ramachandra Institute of Higher Education and Research ( SRIHER)

Chennai
TAMIL NADU
600116
India 
Phone  9491125366  
Fax    
Email  Geetheshmannava@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Geethesh M 
Designation  Post graduate  
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  A6, Department of Anaesthesia and intensive care medicine Sri Ramachandra Institute of Higher Education and Research ( SRIHER)

Chennai
TAMIL NADU
600116
India 
Phone  9491125366  
Fax    
Email  Geetheshmannava@gmail.com  
 
Details of Contact Person
Public Query  
Name  V Rajesh Kumar Kodali 
Designation  PROFESSOR  
Affiliation  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH  
Address  A6, Department of Anaesthesia and intensive care medicine Sri Ramachandra Institute of Higher Education and Research ( SRIHER)

Chennai
TAMIL NADU
600116
India 
Phone  9444230150  
Fax    
Email  vrajesh.kodali@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research India Pin 600116 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Medical college and hospital  
Address  Dr Geethesh, A6 Department of Anaesthesia and intensive care medicine Sri Ramachandra Institute of Higher Education and Research  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Department of Anaesthesia and intensive care medicine   A6 Department of Anaesthesia and intensive care medicine, Sri Ramachandra Institute of Higher Education and Research  
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 Geethesh   Sri Ramachandra Institute of Higher Education and Research SRIHER   A6 Department of Anaesthesia and intensive care medicine Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU 		 9491125366

geetheshmannava@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH ETHICS COMMITTE  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: N74||Female pelvic inflammatory disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ropivacaine with dexmedetomidine   0.4 ml / kg of local anesthetics solution containing 0.25%Ropivacaine and Dexmedetomidine 0.5mcg per kg on each side of lower abdomen poster to quadratus lumborum muscle 
Comparator Agent  Ropivacaine with dexamethasone   0.4ml / kg of local anesthetic solution containing ropivacine 0.25% and dexamethasone 0.1 mg/ kg on each side of lower abdomen Posterior to quadratus lumborum muscle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Who are willing for study
ASA1 and 2 patients who are under going lower abdomi gynecological procedures  
 
ExclusionCriteria 
Details  BMI greater than 30
Multi system disease
Patients with elevated liver enzymes
Patients with CAD and abnormal LV function
Patients with CKD and abnormal RFT
Patients with COPD and other respiratory disorders
Cogulopathy
Emergency Surgeries.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia  0, 30 minutes ,1hour ,2hours
4 hours,8 hours ,12 hours , 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1 Total amount of rescue analgesic consumption
2 Pain score at different time intervals upto 24 hours
3 Number of rescue analgesic dose required
4 Duration of analgesia in hours
5 Hemodynamic changes like heart rate SBP, DBP and SPo2 		 0, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/09/2024 
Date of Study Completion (India) 10/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [geetheshmannava@gmail.com].

  6. For how long will this data be available start date provided 01-06-2025 and end date provided 01-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Local regional anaesthesia  has been extensively applied in the clinical field for achieving  post operative analgesia quadratus  lumborum  block  which  is  a novel inter-fascial  plane  block  has  been  widely  used  for  lower abdominal  gynecological  procedures,   Dexmedetomidine  and dexamethasone  as an adjuvant local anaesthesia  have  been  widely  reported to reduce postoperative  pain  and analgesic  consumption but  there  are  no  studies  comparing  both  these drugs  in  QL block  along  with  ropivacaine  for lower abdominal  gynecological  surgeries.  
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