| CTRI Number |
CTRI/2025/06/088603 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of postoperative pain in major abdominal surgeries |
|
Scientific Title of Study
|
Incidence of severity of postoperative pain in major abdominal oncosurgeries:A prospective observational study from a tertiary cancer centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONALI OPNEJA |
| Designation |
Assistant Professor |
| Affiliation |
MALABAR CANCER CENTRE |
| Address |
Ot block,Anaesthesia department
Malabar cancer centre,
Thalassery
Kodiyeri
Kannur
KERALA
670103
India |
| Phone |
9765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SONALI OPNEJA |
| Designation |
Assistant Professor |
| Affiliation |
MALABAR CANCER CENTRE |
| Address |
Ot block,Anaesthesia department
Malabar cancer centre,
Thalassery
Kodiyeri
KERALA
670103
India |
| Phone |
9765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SONALI OPNEJA |
| Designation |
Assistant Professor |
| Affiliation |
MALABAR CANCER CENTRE |
| Address |
Ot block,Anaesthesia department
Malabar cancer centre,
Thalassery
Kodiyeri
KERALA
670103
India |
| Phone |
9765635728 |
| Fax |
|
| Email |
sopneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar cancer centre
Thalassery
Kodiyeri
kerala
India
670103 |
|
|
Primary Sponsor
|
| Name |
Malabar cancer centre |
| Address |
Malabar cancer centre
Thalassery
Kerala
670103
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 |
| SONALI OPNEJA |
Malabar cancer centre |
Ot block
Anaesthesia department
Malabar cancer centre
Thalassery
670103
kerala
India
Kannur
KERALA |
9765635728
sopneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K828||Other specified diseases of gallbladder, |
|
|
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 |
All patients undergoing major abdominal oncosurgeries |
|
| ExclusionCriteria |
| Details |
Patients not extubated on first postoperative day and those undergoing emergency re-exploration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of postoperative pain in major oncosurgeries |
July 2025 to July 2026 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between demographic parameters and postoperative pain |
July 2025 to July 2026 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
30/07/2025 |
| 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 is being done to know the severity of postoperative pain in major oncosurgeries and its association with surgical and demographic parameters so that we can better manage pain in these patients. |