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CTRI Number  CTRI/2026/02/104261 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Pain during keyhole colorectal surgery and its link to recovery and complications 
Scientific Title of Study   Intraoperative nociceptive responses and postoperative complications in patients undergoing laparoscopic colorectal surgery under general anaesthesia - A prospective 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  Dr Subha R 
Designation  Associate professor  
Affiliation  Regional cancer centre, Thiruvananthapuram  
Address  B-52 Kowdiar gardens Kowdiar P.O. TVPM -3

Thiruvananthapuram
KERALA
695003
India 
Phone  9446700525  
Fax    
Email  drsubharcc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Evlin agnes 
Designation  Junior Resident 
Affiliation  Regional cancer centre, Thiruvananthapuram  
Address  Marakkassery (H) Ochanthuruth P.O. Vypin Ernakulam

Ernakulam
KERALA
682508
India 
Phone  8301872103  
Fax    
Email  evlinagnes5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subha R 
Designation  Associate professor  
Affiliation  Regional cancer centre, Thiruvananthapuram  
Address  B-52 Kowdiar gardens Kowdiar P.O. TVPM -3

Thiruvananthapuram
KERALA
695003
India 
Phone  9446700525  
Fax    
Email  drsubharcc@gmail.com  
 
Source of Monetary or Material Support  
Regional Cancer Centre, Thiruvananthapuram  
 
Primary Sponsor  
Name  Regional Cancer Centre Thiruvananthapuram 
Address  Regional Cancer Centre, Medical college campus, Thiruvananthapuram 
Type of Sponsor  Government funding agency 
 
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 Subha R  Regional cancer center, Thiruvananthapuram   Department of Anaesthesiology
Thiruvananthapuram
KERALA 		 9446700525

drsubharcc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee, Regional Cancer Center, Thiruvananthapuram   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA class 1 & 2
Patients undergoing elective colorectal surgeries  
 
ExclusionCriteria 
Details  BMI more than kg/m^2
Patients who will require intraoperative vasopressor will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Correlation between mean nociceptive response index and post operative complications   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative nociceptive responses using nociceptive response index
 		 At baseline 
To study the amount of opioids required for proper control of intraoperative nociception  At baseline 
To study the perioperative variables amounting to postoperative complications.  30 days 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   28/02/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 [evlinagnes5@gmail.com].

  6. For how long will this data be available start date provided 26-01-2025 and end date provided 26-01-2030?
    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   Nociception is the neural process of encoding and processing noxious stimuli. In conscious state, noxious stimuli cause the sensation of pain as response. Response to noxious stimuli during unconsciousness i.e., during general anaesthesia, however, are different from those in the awake state.Surgical invasion which activates peripheral nociceptors, induces autonomic responses, including increase in blood pressure and heart rate, and decrease in peripheral blood flow, under general anaesthesia.Intraoperative surgical stimulation also increases inflammation and tissue damage during surgery by producing various cytokines and chemokines.C - Reactive protein is a biomarker for such inflammatory process.The nociception produced by surgical invasiveness should be effectively balanced by anaesthesia.Monitoring nociception is an important growing area of investigation. Nociceptive response index (NRI), a recently proposed index is a dimensionless number between 0 & 1. It was developed based on appropriate mathematical models representing autonomic activation responses to noxious stimulation and considering heart rate, systolic blood pressure and perfusion index in calculating the numerical value. Hirose et al., evaluated its utility to discriminate nociceptive responses to a small and large skin incision in laparotomy and found that NRI quantitatively discerned the differences. They suggested that NRI could be used to assess either real time nociceptive responses or averaged nociceptive responses throughout surgery without special equipment.
A higher level of surgical stimulus is associated with more physiological responses which in turn is thought to be associated with incidence of postoperative morbidity and mortality.This study is based on the hypothesis that intraoperative nociceptive responses can add on to postoperative complications in patients undergoing colorectal surgery under general anaesthesia.
Postoperative complications can be classified as per modified Clavien – Dindo classification system.
 
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