| CTRI Number |
CTRI/2025/07/090080 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Perfusion Index and Visual analogue scale for post operative pain assessment |
|
Scientific Title of Study
|
Comparison of Perfusion Index with Visual Analogue Scale as a post-operative pain assessment tool following lower limb surgeries under subarachnoid block: An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECKMCMLR02/2025/36 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi R Aithal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anesthesiology
Kasturba Medical College Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9945857060 |
| Fax |
|
| Email |
aithal.rr73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi R Aithal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anesthesiology
Kasturba Medical College Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9945857060 |
| Fax |
|
| Email |
aithal.rr73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi R Aithal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Anesthesiology
Kasturba Medical College Lighthouse Hill Road Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9945857060 |
| Fax |
|
| Email |
aithal.rr73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Mangalore
Manipal Academy of Higher Education Manipal Dakshina Kannada 575001 |
|
|
Primary Sponsor
|
| Name |
Dr. Rashmi R Aithal |
| Address |
Department of Anesthesiology Kasturba Medical College Lighthouse hill Road Mangalore
575001 |
| 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 Rashmi R Aithal |
Kasturba Medical College Mangalore |
Department of Anesthesiology
Kasturba Medical college Lighthouse hill Road Mangalore 575001
Dakshina Kannada
KARNATAKA |
9945857060
aithal.rr73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R448||Other symptoms and signs involvinggeneral sensations and perceptions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective lower limb surgeries under spinal anesthesia
2. ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 65 years
2. Patient refusal
3. Contraindication to spinal anesthesia
4. Patients with peripheral vascular disease
5. Uncooperative patients
6. Patients with Cognitive dysfunction
7. Patients with chronic pain disorder
8. Pregnant and Lactating females
9. Patients requiring perioperative inotropes or vasodilators |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of Perfusion index with Visual analogue scale score for post operative pain assessment |
1. Baseline
2. Patient complains of Pain postoperatively
3. 30 minutes after Paracetamol intravenous infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of Perfusion Index with Heart Rate and Mean arterial blood pressure |
1. Baseline
2. Patient complains of Pain postoperatively
3. 30 minutes after Paracetamol intravenous infusion |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
04/08/2025 |
| 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="0"
Months="4"
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
|
This is a prospective observational study to compare the effectiveness of Perfusion Index (PI) and Visual Analogue scale (VAS) for postoperative pain assessment in patients undergoing lower limb surgeries under subarachnoid block. The primary outcome is to obtain correlation between PI and VAS score for post operative pain assessment. The secondary outcome is to correlate PI with hemodynamic parameters like Heart rate and Mean arterial blood pressure |