| CTRI Number |
CTRI/2023/08/056142 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Post operative pain among men and women after a major surgery. |
|
Scientific Title of Study
|
Comparison of gender difference on post operative pain perception in adults following major surgery under General Anaesthesia |
| 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. Aiswarya Vijay |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi |
| Address |
1st floor, Main OT building, Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9894117683 |
| Fax |
|
| Email |
aiswarya0410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. G Usha |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi |
| Address |
Ground Floor, Main OT Building, Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8447795934 |
| Fax |
|
| Email |
doctorgusha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr, G Usha |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi |
| Address |
Ground Floor, Main OT Building, Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9447795934 |
| Fax |
|
| Email |
doctorgusha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjang Hospital |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Aiswarya Vijay |
Vardhman Mahavir Medical College and Safdarjang Hospital |
1st floor, Main OT Building, Department of Anaesthesia.
New Delhi
DELHI |
9894117683
aiswarya0410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJANG HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Patients posted for Elective Major Surgery under General Anaesthesia with Epidural Analgesia |
|
| ExclusionCriteria |
| Details |
Patients with chronic pain.
Patients with Neurological disorders and Psychiatric diseases.
Patients with coagulation defects.
Patients with previous history of hypersensitivity reactions to local anaesthetics.
Patients with obesity(BMI>30KG/M2). |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate gender difference on post operative pain perception in adults following major surgery under general anaesthesia |
15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 mins, 3 hours, 4 hours, 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate gender difference in response to epidural analgesia.
|
15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 6 hours |
| To assess hemodynamic changes following epidural analgesia. |
15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 30 minutes,2 hours, 4 hours, 6 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
17/08/2023 |
| 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="6"
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
|
The study is to evaluate gender difference on pain perception in adults following major surgery under general anaesthesia. It is a prospective comparitive observational study with 64 participents(32 men and 32 women) in age group 18-65 belonging to ASA grade 1 and 2. Initially an epidural catheter will be inserted in the desired space and test dose given, patient will then be induces under general anaesthesia. After completion of the surgery, patient will be extubated and pain will be recorded as per numerical pain rating scale, if >4 epidural analgesia with Inj 0.25% Bupivacaine given, pain severity will be assessed every 15 mins for first hour, every 30 minutes for next one hour and then two hourly for next 6 hours. Difference in pain perception and response to epidural analgesia among men and women noted and statistical analysis done. |