| CTRI Number |
CTRI/2021/08/036005 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating Post Operative Pain after General Anaesthesia in Post operative unit |
|
Scientific Title of Study
|
Post Operative Pain Assessment in Post Anaesthesia Care Unit After General Anaesthesia: A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shwetha Nayak |
| Designation |
Post graduate |
| Affiliation |
K S Hegde medical Academy |
| Address |
Department of Anaesthesia and operation theatre technology Justice K S Hegde Charitable Hospital Deralakatte Mangalore
Department of Anaesthesia and operation theatre technology Justice K S Hegde Charitable Hospital Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9482359733 |
| Fax |
|
| Email |
nayakshwetha227@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murali Shankar Bhat A |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde medical Academy |
| Address |
Department of Anaesthesiology Justice K S Hegde Charitable Hospital Deralakatte Mangalore
Department of Anaesthesiology Justice K S Hegde Charitable Hospital Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8884537753 |
| Fax |
|
| Email |
muralishankarbhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shwetha Nayak |
| Designation |
Post graduate |
| Affiliation |
K S Hegde medical Academy |
| Address |
Department of Anaesthesia and operation theatre technology Justice K S Hegde Charitable Hospital Deralakatte Mangalore
Department of Anaesthesia and operation theatre technology Justice K S Hegde Charitable Hospital Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
5750018
India |
| Phone |
9482359733 |
| Fax |
|
| Email |
nayakshwetha227@gmail.com |
|
|
Source of Monetary or Material Support
|
| Justice K S Hegde Charitable Hospital Nithyananda Nagar Deralakatte Manglore |
|
|
Primary Sponsor
|
| Name |
Shwetha Nayak |
| Address |
Department of Anaesthesia and operation theatre technology Justice K S Hegde Charitable Hospital Deralakatte Mangalore |
| 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 Murali Shankar Bhat A |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology Deralakatte Mangalore
Dakshina Kannada
KARNATAKA |
8884537753
muralishankarbhat@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients, Patients who underwent surgery with general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal, Patient who cannot comprehend, un co-operative patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pain score and patients satisfaction of pain relief in PACU after general anaesthesia |
8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the different pain management methods |
8 hours |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2021 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Better post-operative pain management will improve the patient satisfaction and surgical outcome |