| CTRI Number |
CTRI/2025/09/094263 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of the different pain assessment scale for postoperative pain assessment in patients undergoing abdominal surgery |
|
Scientific Title of Study
|
Comparison of the Hundred paisa pain scale with Numeric rating scale, and verbal rating scale for postoperative pain assessment in patients undergoing abdominal surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhay Raj Singh |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital
West DELHI 110029 India |
| Phone |
08285640262 |
| Fax |
|
| Email |
abhayrajsingh650@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dimple Pande |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital C3, type 4 quarters, Safdarjung hospital staff quarters, west kidwai nagar, delhi South DELHI 110029 India |
| Phone |
09868435534 |
| Fax |
|
| Email |
drdimplepande@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Abhay Raj Singh |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vardhman Mahavir Medical College and Safdarjung Hospital
South DELHI 110029 India |
| Phone |
09868435534 |
| Fax |
|
| Email |
abhayrajsingh650@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, VMMC and Safdarjung hospital, Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
department of anaesthesia, New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Abhay Raj Singh |
main OT building, Department of Anaesthesia |
VMMC and Safdarjung hospital, Delhi South DELHI |
8285640262
abhayrajsingh650@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| 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 18-65 years
• Belongs to American Society of Anaesthesiologist Physical Status I, II or III
• Patient undergoing abdominal surgery under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
• Patient not able to communicate or comprehend hindi/ english
• Patient with known mental health disease , hearing loss
• Anticipated Prolonged surgery (duration of surgery more than 120 minutes)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the correlation between the hundred paisa pain scale with numeric rating scale, and verbal rating scale for post operative pain assessment in patients undergoing abdominal surgery. |
30 minutes , 45 minutes , 2 hours , 6 hours , 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the patients preferred pain scale.
|
at 24 hrs |
| To assess the correlation between the hundred paisa pain scale, numeric rating scale, and verbal rating scale with education qualification |
|
| To compare patient satisfaction with hundred paisa pain scale, numeric rating scale, and verbal rating scale |
|
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
01/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The assessment of postoperative pain is a crucial
aspect of patient care, demanding accurate and reliable scales to guide
effective pain management strategies. Postoperative pain management guideline
recommends the use of validated self-reported pain scales including Visual
Analogue scales (VAS), Numeric rating scale(NRS) and verbal rating scale (VRS). The assessment of postoperative pain is a crucial
aspect of patient care, demanding accurate and reliable scales to guide
effective pain management strategies. Postoperative pain management guideline
recommends the use of validated self-reported pain scales including Visual
Analogue scales (VAS), Numeric rating scale(NRS) and verbal rating scale (VRS). The assessment of postoperative pain is a crucial
aspect of patient care, demanding accurate and reliable scales to guide
effective pain management strategies. Postoperative pain management guideline
recommends the use of validated self-reported pain scales including Visual
Analogue scales (VAS), Numeric rating scale(NRS) and verbal rating scale (VRS). |