| CTRI Number |
CTRI/2025/10/095935 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing eye pupil size and pain scale for checking pain after spinal anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of visual analogue scale and pupillary diameter for postoperative pain assessment following spinal 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 Aravindh S |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8056052549 |
| Fax |
|
| Email |
dr.aravindh97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.R.Krishnaprabu |
| Designation |
Head of the department |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9943770977 |
| Fax |
|
| Email |
drkrishnaprabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aravindh S |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8056052549 |
| Fax |
|
| Email |
dr.aravindh97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur |
|
|
Primary Sponsor
|
| Name |
Dr Aravindh S |
| Address |
Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur |
| Type of Sponsor |
Other [self] |
|
|
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 Aravindh S |
sri Venkateshwara Medical College Hospital and research centre |
Department of Anaesthesiology,Main OT complex,13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
13-A, Pondy-Villupuram main road, Sri venkateshwaraa medical college hospital and research centre, Ariyur
Pondicherry
PONDICHERRY |
8056052549
dr.aravindh97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee ( Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 65 years of either sex.
Patients scheduled to undergo lower abdominal surgical procedures under Spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients receiving general anaesthesia /epidural analgesia.
2. Patients with ocular conditions affecting the iris, cornea, or retina.
3. Patients with psychiatric disorders or an inability to understand or use the Visual Analogue Scale (VAS) for pain assessment.
4. Patients who received Drugs that can alter pupillary diameter like
Anticholinergic agents: Atropine, Glycopyrrolate, Scopolamine
Sympathomimetic agents: Epinephrine, phenylephrine, ephedrine.
5. Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between pupillary diameter and Visual Analogue Scale (VAS) scores for postoperative pain assessment at 4, 6, 8, 12, and 24 hours after spinal anaesthesia |
Assessed at 4 hours, 6 hours, 8 hours, 12 hours , and 24 hours after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of haemodynamic parameters (heart rate, blood pressure) with changes in pupillary diameter and VAS scores at the same postoperative time points. |
At 4, 6, 8, 12, and 24 hours after spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
22/10/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This study aims to compare visual analogue scale with pupillary diameter for assessment of postoperative pain in patients undergoing lower abdominal surgeries under spinal anaesthesia It is a prospective observational study conducted on 90 patients Pain scores using visual analogue scale and pupillary diameter using handheld infrared pupillometer will be recorded at 4 6 8 12 and 24 hours after surgery along with haemodynamic parameters The correlation between pupillary diameter and visual analogue scale will be evaluated to determine if pupillometry can serve as an objective tool for pain assessment |