| CTRI Number |
CTRI/2025/11/097803 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
It is a Study To compare the one drug and its combination with Opiods for post operative pain releif in peadiatric thoracotomy. |
|
Scientific Title of Study
|
Comparative study of Ropivacaine and Ropivacaine with Fentanyl for post operative continuous epidural analgesia in paediatric thoracotomy. |
| 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. Alpeshji Kirtiji Thakor |
| Designation |
M.D. Anaesthesiology resident |
| Affiliation |
B.J.MEDICAL COLLEGE,AHMEDABAD |
| Address |
Room no.A/103 Phase 2 , Civil
Hospital campus Haripura Asarawa
AHMEDABAD 380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7096534112 |
| Fax |
|
| Email |
alpeshthakor1015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhavana Raval |
| Designation |
Proffesor(HG),Department of Anaesthesia |
| Affiliation |
B.J.MEDICAL COLLEGE,AHMEDABAD |
| Address |
F3-Department of Anaesthesia,
1st floor Trauma centre ,Civil Hoapital, B.J.MEDICAL COLLEGE,
AHMEDABAD
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bhavana Raval |
| Designation |
Proffesor(HG),Department of Anaesthesia |
| Affiliation |
B.J.MEDICAL COLLEGE,AHMEDABAD |
| Address |
F3-Department of Anaesthesia,
1st floor Trauma centre ,Civil Hoapital, B.J.MEDICAL COLLEGE,
AHMEDABAD
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373182 |
| Fax |
|
| Email |
drbhavanaraval@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Paediatric OT,1200 bed hospital, Civil Hospital Ahmedabad And Dr. Alpeshji Kirtiji Thakor |
|
|
Primary Sponsor
|
| Name |
Government supply and Dr Alpeshji Kirtiji Thakor |
| Address |
F3-Department of Anaesthesia,
1st floor Trauma centre ,Civil Hoapital, B.J.MEDICAL COLLEGE,
AHMEDABAD-380016 |
| 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 ALPESHJI KIRTIJI THAKOR |
O3-Third floor ,Peadiatric Surgical OT,1200 Bed Hospital. |
1200 BED HOSPITAL,CIVIL
HOSPITAL AHMEDABAD
GUJARAT 380016
Ahmadabad
GUJARAT |
7096534112
alpeshthakor1015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee,B.J.Medical college and civil hospital Ahmedabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Ropivacaine 0.2% epidural bolus dose followed by inj. Ropivacaine 0.1% epidural continuous infusion.
|
Inj. Ropivacaine 0.2% Epidural bolus dose 0.3ml/kg followed by Inj. Ropivacaine 0.1% Epidural continuous infusion 0.2ml/kg/hr
via epidural route and continue till 48 hours. |
| Comparator Agent |
Inj. Ropivacaine with fentanyl epidural bolus dose followed by inj. Ropivacaine with fentanyl continuous infusion |
inj. Ropivacaine 0.2% epidural bolus dose 0.3ml/kg with inj. Fentanyl 1mcg/kg followed by Inj. Ropivacaine 0.1% Epidural continuous infusion 0.2ml/kg/hr with Inj. Fentanyl 0.5mcg/kg/hr via epidural route and continue till 48 hours |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.consent from legally authorized representative.
2.ASA grade II,III |
|
| ExclusionCriteria |
| Details |
1.ASA grade I,IV,V
2.Known allergy to Fentanyl and Ropivacaine.
3.Patients with cougulopathies,thrombocytopenia and Bleeding disorders
4.Local Infections at epidural insertion site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare between Ropivacaine and Ropivacaine with fentanyl for post operative analgesia. |
patient assessment for pain score and any complication done till 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the hemodynamics parameters. |
Monitoring done till Postoperative 48 hours(2 Days) |
| To assess for Complications & Sedation. |
Monitoring done till Postoperative 48 hours(2 Days) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/12/2025 |
| 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 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
|
Post operative pain management remains a clinical challenge following Thoracotomies. Local anaesthetics with opioids via epidural route offer a solutions for improving pain control with minimizing systemic side effects. |