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CTRI Number  CTRI/2026/01/101244 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
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 the effect of introducing ropivacaine with dexmedetomidine and ropivacaine with tramadol into the abdominal cavity for postoperative pain relief after laparoscopic surgery 
Scientific Title of Study   A comparative study of intraperitoneal instillation of ropivacaine with dexmedetomidine and ropivacaine with tramadol for post operative analgesia in laparoscopic surgery 
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 Aashalakshmi Menon P 
Designation  Second year resident doctor 
Affiliation  B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL 
Address  F3 First floor Department of Anaesthesia Civil hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  9847765832  
Fax    
Email  aashalakshmip@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anisha Chokshi 
Designation  Professor HG 
Affiliation  B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL 
Address  F3 First floor Department of Anaesthesia Civil hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  9824497076  
Fax    
Email  abhinisha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anisha Chokshi 
Designation  Professor HG 
Affiliation  B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL 
Address  F3 First floor Department of Anaesthesia Civil hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  9824497076  
Fax    
Email  abhinisha@gmail.com  
 
Source of Monetary or Material Support  
Government of Gujarat Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
 
Primary Sponsor  
Name  Government of Gujarat 
Address  Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
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 AASHALAKSHMI MENON P  B J MEDICAL COLLEGE AND CIVIL HOSPITAL   4th floor Major operation theatre Trauma center building Civil hospital campus Asarwa Ahmedabad
Ahmadabad
GUJARAT 		 9847765832

aashalakshmip@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Academic Studies B.J. Medical College And Civil Hospital Ahmedabad  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraperitoneal instillation of ropivacaine with dexmedetomidine  At the end of laparoscopic cholecystectomy Intraperitoneal instillation of Inj. Ropivacaine 0.2% 18 ml + Inj. Dexmedetomidine 1mcg/kg at the operative site through surgical port  
Comparator Agent  Intraperitoneal instillation of ropivacaine with tramadol  At the end of laparoscopic cholecystectomy Intraperitoneal instillation of Inj. Ropivacaine 0.2% 18 ml + Inj. Tramadol 2mg/kg at the operative site through surgical port  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I, II, and III, Patients scheduled for elective laparoscopic surgeries 
 
ExclusionCriteria 
Details  ASA grade IV or V, Patients refusing to give consent, History of allergy to local anaesthetic agents, Pregnant women, History of previous abdominal surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare duration of analgesia  Postoperative 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor postoperative hemodynamic parameters in both groups  Postoperative 24 hours 
To evaluate the side effects and complications   Postoperative 24 hours 
 
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   N/A 
Date of First Enrollment (India)   26/01/2026 
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="0"
Months="11"
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   Post operative pain management remains a clinical challenge following laparoscopic surgeries. Local anaesthetics offer a potential solution for improving pain control while minimizing systemic side effects. Ropivacaine is a long acting anaesthetic known for its efficacy and favourable safety profile in providing prolonged analgesia. Adjuvant medications like dexmedetomidine an alpha 2 adrenergic agonist and tramadol an opioid sparing analgesic prolong the duration of local anaesthetic action.This study is based on the hypothesis that intraperitoneal instillation of Ropivacaine with dexmedetomidine can yield a superior effect in reducing postoperative pain when compared to intraperitoneal instillation of Ropivacaine with tramadol  
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