| CTRI Number |
CTRI/2025/10/095763 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparasion between Serratus Posterior Superior Intercostal block and Erector Spinae block in children for pain ttreatment |
|
Scientific Title of Study
|
Comparative study of Continuous Serratus Posterior Superior Intercostal plane block with Continuous Erector Spinae Plane Block in Pediatric patients for postoperative analgesia in thoracotomy: A randomised control trial |
| 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 POONAM KUMARI |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room No-506, OT complex 5th floor, Department of Anaesthesiology, Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR POONAM KUMARI |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room No-506, OT complex 5th floor, Department of Anaesthesiology, Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR POONAM KUMARI |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room No-506, OT complex 5th floor, Department of Anaesthesiology, Aiims Patna
Patna
BIHAR
801507
India |
| Phone |
9473199126 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,All India Institute of Medical Sciences Patna. Pin code-801507, Bihar, India
|
|
|
Primary Sponsor
|
| Name |
All India institute of Medical SciencesPatna |
| Address |
Department of anaesthesiology,All India Institute of Medical Sciences Patna. Pin code-801507, Bihar, India
|
| Type of Sponsor |
Government medical college |
|
|
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 POONAM KUMARI |
All India Institute of Medical sciences,Patna |
Pediatric OT 6th floor, IPD building, B block. AIIMS Patna
Patna
BIHAR |
09473199126
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Aiims Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
continuous erector spinae plane block |
continuous erector spinae plane block given after general anaesthesia.
Dose: 0.5 ml/kg of 0.25% bupivacaine will be injected through catheter 6th hourly |
| Intervention |
continuous serratus posterior superior plane block |
will receive continuous serratus superior plane block after general anaesthesia.
Dose :.0.5 ml/kg of 0.125% bupivacaine will be given through catheter 6th hourly |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II
Scheduled for the right or left thoracotomy surgery |
|
| ExclusionCriteria |
| Details |
Any coagulation abnormality
Raised intracranial pressure
Deformity of the thoracolumbar spine
Local infection at the site of catheter placement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare 24 hour Post-operative Fentanyl consumptions |
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of first rescue analgesia required
FLACC score postoperative period at 30 min, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour
Adverse effect like pneumothorax, nausea, vomiting
|
24 hour |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
31/10/2025 |
| 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
|
– Peripheral nerve blocks are known to be effective for pain management during and after surgeries. US guided serratus posterior superior plane block is safe and effective technique for multimodal pain management in postoperative period.This study is novel as no studies have been done earlier to compare continuous serratus posterior superior plane block with continuous erector spinae plane block for thoracotomy surgery. So, our study is focused on finding out which approach among them is more effective in terms of requirement of analgesics, pain scores and adverse effects. |