| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kumaraguru5488@gmail.com].
- 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.
- 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. |