| CTRI Number |
CTRI/2025/04/085872 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Peri-operative Pain Audit using multiple analgesic techniques in children of a single institute |
|
Scientific Title of Study
|
Audit of Perioperative multi-modal analgesic modalities in children: single institute, prospective, observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dixita Shetty |
| Designation |
Senior Registrar, post doctoral fellowship in paediatric anaesthesia |
| Affiliation |
Narayana Health SRCC Childrens Hospital |
| Address |
SRCC Hospital, 3rd floor, Ot building, Mahalakshmi.
1, 1A Keshavrao Khadye Marg, Mahalakshmi, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400034
India |
| Phone |
7719927465 |
| Fax |
|
| Email |
d.shetty93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dixita Shetty |
| Designation |
Senior Registrar, post doctoral fellowship in paediatric anaesthesia |
| Affiliation |
Narayana Health SRCC Childrens Hospital |
| Address |
1403, A, Building no 12, Varad Heights, Tilaknagar, Chembur, Mumbai.
1, 1A Keshavrao Khadye Marg, Mahalakshmi, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400089
India |
| Phone |
7719927465 |
| Fax |
|
| Email |
d.shetty93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dixita Shetty |
| Designation |
Senior Registrar, post doctoral fellowship in paediatric anaesthesia |
| Affiliation |
Narayana Health SRCC Childrens Hospital |
| Address |
SRCC Hospital, 3rd floor, Ot building, Mahalakshmi.
1, 1A Keshavrao Khadye Marg, Mahalakshmi, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400034
India |
| Phone |
7719927465 |
| Fax |
|
| Email |
d.shetty93@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NH SRCC Childrens Hospital |
| Address |
1-1A, haji ali park, K. Khadye Marg, Mahalakshmi, Mumbai- 400034 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Dixita Shetty |
NH SRCC Childrens Hospital |
3rd floor, ot area, SRCC Childrens hospital, 1-1a Khadye marg, Mahalakshmi, mumbai 400034
Mumbai
MAHARASHTRA |
7719927465
d.shetty93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHSRCC Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Undergoing surgery elective or emergency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Undergoing elective and emergency surgery
2. Requiring a minimum stay of 1 day post operatively
|
|
| ExclusionCriteria |
| Details |
1. Neonates
2. Day care procedures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Following data will be collected:
1. Name of surgery
2. Comorbities– ASA status
3. Intraoperative analgesic medication used
4. Regional anaesthetic plan, if any
5. Type of regional anaesthetic technique used
6. Single shot versus catheter technique
7. Post-operative pain scores
8.Intraoperative and post-operative complications
9. Post-operative analgesic regimen
10. Break through pain if any and its management
11. Management of any complications
12. Compliance rates – no. of unfilled data forms, incomplete charts etc. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post-operative prescription of opioids and associated side effects
2. Assessment of adequacy of the analgesic regimen |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
Multi modal analgesia including regional analgesic and
anaesthetic techniques are a corner stone of the anaesthesia practice at our
center provided to all patients undergoing surgery. This study would look into
obtaining highly audited information and practice methodology regarding the use
and efficacy of the multi-modal analgesic protocols specific to our institute.
The information garnered would give way to further quality improvement,
research avenues and improved patient satisfaction and safety. We would also
be collecting data on any complications and looking into the circumstances that
led to the same. Data regarding post operative analgesic regimens, opioid and non steroidal
anti inflammatory drug usage will
also be collected looking to better our post-operative patient comfort as well
as enhancing recovery following surgery.
|