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CTRI Number  CTRI/2025/01/078970 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 15/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Serratus Posterior Superior Intercostal plane block and Epidural for the treatment of pain in young patient in chest operation 
Scientific Title of Study   Comparative study of Continuous Serratus Posterior Superior Intercostal plane block With Thoracic Epidural in adult 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  Poonam Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Room No-506,5th floor OT complex,IPD Bulding, Department of Anaesthesiology, AIIMS Patna

Patna
BIHAR
801507
India 
Phone  9473199126  
Fax    
Email  drpoonam1981@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Poonam Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Room No-506,5th floor OT complex,IPD Bulding, Department of Anaesthesiology, AIIMS Patna


BIHAR
801507
India 
Phone  9473199126  
Fax    
Email  drpoonam1981@gmail.com  
 
Details of Contact Person
Public Query  
Name  Poonam Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Room No-506,5th floor OT complex,IPD Bulding, Department of Anaesthesiology,AIIMS Patna


BIHAR
801507
India 
Phone  9473199126  
Fax    
Email  drpoonam1981@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences,Patna,Phulwari sharif, Pin code-801507.india 
 
Primary Sponsor  
Name  All India institute of Medical SciencesPatna 
Address  Department of Anaesthesiology,All India institute of Medical Sciences,Patna 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPoonam Kumari  Department of Anaesthesiology, All India Institute of Medical sciences,Patna  6th floor OT-16 & 20, IPD Bulding, AIIMS Patna
Patna
BIHAR 		 9473199126

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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J65||Pneumoconiosis associated with tuberculosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Continuous Serratus Posterior Superior Plane Block  continuous serratus posterior superior plane block given with 0.125%bupivacaine according to the dermatomal coverage Postoperative period: 0.125%bupivacaine will be given when the NRS score is more than 4, and there will be a minimum gap of 4 hours between the two bolus doses 
Comparator Agent  Thoracic Epidural  the patient will receive epidural anesthesia in lateral position at T7-T8 level. 1.5 ml/segment 0.125%bupivacaine will be given for dermatomal coverage and in postoperative period 0.125%bupivacaine will be given for dermatomal coverage when NRS more than4 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA I/II

Scheduled for thoracotomy surgery
 
 
ExclusionCriteria 
Details  Mental disorder

Communication failure

Inability to understand the functionality of patient-controlled analgesia pump
 
 
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 Postoperative Local anaesthestic consumption   24 hour  
 
Secondary Outcome  
Outcome  TimePoints 
1.Time of first rescue analgesic required

2.Intra operative opioid (fentanyl) consumption

3.Total opioid (fentanyl) consumption in 24-hour postoperative period

4.NRS score: postoperative period at 30 min, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour at rest & movement

5.Adverse effect : Hypotension, Bradycardia, Pneumothorax, Nausea vomiting
 		 30 min, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   The management of thoracic postoperative pain is a challenging one. A variety of methods are used to address pain, and they incorporate the principles of multimodal analgesia. Regional anesthesia has a key role in multimodal analgesia that helps in alleviating perioperative pain and also decreases the consumption of other opioid analgesics.1 epidural is the gold standard for postoperative pain management.
Peripheral nerve blocks are known to be effective for pain management during and after surgeries. Continuous serratus posterior superior plane block is safe and effective technique for multimodal pain management during postoperative period.
 
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