| CTRI Number |
CTRI/2024/06/069493 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of post operative pain and patient satisfaction with pain management |
|
Scientific Title of Study
|
To study prevalence of post operative pain and patient satisfaction with pain management |
| 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 Susheela Taxak |
| Designation |
Senior Professor |
| Affiliation |
Pt. B.D.S. PGIMS ROHTAK |
| Address |
Department of Anesthesiology and Critical Care
PT. B.D.S. PGIMS
ROHTAK
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9896067416 |
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheela Taxak |
| Designation |
Senior Professor |
| Affiliation |
Pt. B.D.S. PGIMS ROHTAK |
| Address |
Department of Anesthesiology and Critical Care
PT. B.D.S. PGIMS
ROHTAK
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9896067416 |
| Fax |
|
| Email |
susheelataxak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shally Jain |
| Designation |
PG student |
| Affiliation |
PT. B.D.S. PGIMS ROHTAK |
| Address |
Department of Anesthesiology and Critical Care
PT. B.D.S. PGIMS ROHTAK HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
7827669944 |
| Fax |
|
| Email |
shallyjain147@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care
PGIMS ROHTAK
HARYANA
INDIA
PINCODE 124001 |
|
|
Primary Sponsor
|
| Name |
Pt BDS PGIMS ROHTAK |
| Address |
Department of Anesthesiology and Critical Care
PT. B.D.S. PGIMS ROHTAK
HARYANA
INDIA
PINCODE 124001
HARYANA
INDIA
PINCODE- 124001 |
| 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 |
| Dr Susheela Taxak |
Pt.B.D.S PGIMS ROHTAK |
Department of Anesthesiology and Critical Care
Pt. B.D.S. PGIMS ROHTAK
Rohtak
HARYANA |
9896067416
susheelataxak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D. Sharma PGIMS/UHS , ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA I - III
Undergoing elective surgery
General or Regional anaesthesia |
|
| ExclusionCriteria |
| Details |
History of chronic pain management
History of psychiatric treatment
On anti epileptic drugs
Pregnant female
Unable to communicate
Undergoing ophthalmic surgeries
Drug abuser
Not willing for consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out prevalence of post operative pain in patients undergoing elective surgery |
After 24 hr of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Characteristics of pain reported, level of patient satisfaction with post operative pain management,factors associated in the patient satisfaction with pain management. |
24 hour after surgery |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
10/07/2024 |
| 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 assigned to assess the prevalence of post operative pain and patient satisfaction with pain management in our institute using questionnaire based on American Pain Society - Pain Outcome Questionnaire revised ( APS-POQ-R). It can be presumed that finding of our study could identify the special needs to strengthen quality of post operative pain management. |