| CTRI Number |
CTRI/2025/07/090013 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of Bupivacaine vs Bupivacaine with Dexamethasone in erector spinae block for postoperative pain in paediatric patients undergoing video assisted thoracoscopic surgeries. |
|
Scientific Title of Study
|
Efficacy of Bupivacaine vs Bupivacaine with Dexamethsaone in Erector spinae block for postoperative pain in paediatric patients undergoing video assisted thoracoscopic surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
erryash@gmail.com |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR DY PATIL VIDYAPEETH, PUNE |
| Address |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9971098871 |
| Fax |
- |
| Email |
erryash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor |
| Affiliation |
DR DY PATIL VIDYAPEETH, PUNE |
| Address |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
- |
| Email |
ksonal0711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor |
| Affiliation |
DR DY PATIL VIDYAPEETH, PUNE |
| Address |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
- |
| Email |
ksonal0711@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th floor, Hi-tech building, Dr D.Y. Paril Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India Pincode-411018 |
|
|
Primary Sponsor
|
| Name |
DR ASHISH ERRY |
| Address |
Department of Anesthesia, 5th floor, Hi-tech building, Dr D.Y. Patil Medical College and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| 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 ASHISH ERRY |
DR DY PATIL HOSPITAL and RESEARCH CENTRE |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9971098871
-
erryash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS SUB-COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B951||Streptococcus, group B, as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Bupivacaine 0.125 0.5ml/kg in erector spinae block post operatively |
| Intervention |
Dexamethasone |
Dexamethasone 0.2 mg/kg added to Bupivacaine 0.125% 0.5ml/kg for erector spinae block in pediatric patients undergoing VATS for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients ASA 1 & 2
Patients undergoing VATS |
|
| ExclusionCriteria |
| Details |
Patients m0re than 10 years of age
Patients with coagulopathies
ASA 3 & 4
Parents who did not give consent
Patients allergic to either dexamethasone or bupivacaine |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Bupivacaine vs Dexamethasone with Bupivacaine in erector spinae block in pediatric patients undergoing VATS |
After giving erector spinae block FLACC score was used to asses postoperative pain and rescue analgesia given accordingly and time noted to compare the efficacy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/07/2025 |
| 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
|
It is a prospective, randomized, single blinded comparative study to compare the analgesic efficacy of dexamethasone as an adjuvant to bupivacaine versus bupivacaine in erector spinae block post operatively in pediatric patients undergoing VATS. Parameters that will be compared between the two groups will be the duration of analgesia, time to rescue analgesia and number of rescue analgesia given. |