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CTRI Number  CTRI/2026/02/103133 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A Study on Methods Used to Control Pain After Laparoscopic Surgery 
Scientific Title of Study   Effectiveness of various post operative pain management modalities among patients undergoing laproscopic surgeries an observational 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  Kumaragurudhasan  
Designation  Pg scholar 
Affiliation  SRM Institute Of Science and Technology 
Address  Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.

Chennai
TAMIL NADU
603203
India 
Phone  6380831267  
Fax    
Email  kumaraguru5488@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Karthik 
Designation  Associate professor 
Affiliation  SRM Institute Of Science and Technology 
Address  Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.

Chennai
TAMIL NADU
603203
India 
Phone  9444586662  
Fax    
Email  karthikk1@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kumaragurudhasan  
Designation  Pg scholar 
Affiliation  SRM Institute Of Science and Technology 
Address  Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.

Chennai
TAMIL NADU
603203
India 
Phone  6380831267  
Fax    
Email  kumaraguru5488@gmail.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology, SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India 
 
Primary Sponsor  
Name  SRM Institute of Science and Technology 
Address  SRM Institute of Science and Technology, SRM medical college Hospital and Research Centre, SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203 India 
Type of Sponsor  Research institution and hospital 
 
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 Karthik K  SRM Medical College and hospital  Room No D4-26,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India
Chennai
TAMIL NADU 
9444586662

karthikk1@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged 18 years and above.
2.Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
3.Patients willing to provide informed consent to participate in the study. 
 
ExclusionCriteria 
Details  Patients with ASA Physical Status III (i.e., ASA III, IV,)
Patients with psychiatric or cognitive impairments affecting pain reporting.
Patients with known hypersensitivity or allergy to any analgesic medications used in the study (e.g., opioids, NSAIDs, local anesthetics). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patient satisfaction with postoperative pain management measured using the ASSIST - patient satisfaction survey (validated questionnaire).  Patient satisfaction score assessed using the ASSIST patient satisfaction questionnaire, recorded once between 24 hours post operatively and the time of hospital discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="259"
Sample Size from India="259" 
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)   23/02/2026 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  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 [kumaraguru5488@gmail.com].

  6. For how long will this data be available start date provided 21-08-2026 and end date provided 23-08-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is a prospective observational cohort study conducted at a tertiary care hospital to evaluate the effectiveness of various post-operative pain management modalities in patients undergoing laparoscopic surgeries. Post-operative pain management practices used as part of routine clinical care will be documented, and patient satisfaction at 24 hours post-surgery will be assessed. The study aims to identify effective pain management approaches that improve post-operative comfort and recovery. 
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