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CTRI Number  CTRI/2026/03/105927 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A observational study to assess pain relief using ultrasound-guided nerve block in patients with acute rib fractures. 
Scientific Title of Study   Ultrasound-guided Rhomboid Intercostal and Subserratus Plane Block as an Analgesic Modality in Acute Rib Fractures: An Observational Study. 
Trial Acronym  RISS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Kamble 
Designation  Associate Professor  
Affiliation  BJGMC and Sassoon General Hospital, Pune 
Address  Anaesthesia department,3rd floor, 11 storey building,BJGMC and Sassoon General Hospital, Jai Prakash Narayan Road, Railway Station Rd, Agarkar Nagar, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  8806049448  
Fax    
Email  nehakamble_84@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neha Kamble 
Designation  Associate Professor  
Affiliation  BJGMC and Sassoon General Hospital, Pune 
Address  Anaesthesia department,3rd floor, 11 storey building,BJGMC and Sassoon General Hospital, Jai Prakash Narayan Road, Railway Station Rd, Agarkar Nagar, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  8806049448  
Fax    
Email  nehakamble_84@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Kamble 
Designation  Associate Professor  
Affiliation  BJGMC and Sassoon General Hospital, Pune 
Address  Anaesthesia department,3rd floor, 11 storey building, BJGMC and Sassoon General Hospital, Jai Prakash Narayan Road, Railway Station Rd, Agarkar Nagar, Pune, Maharashtra 411001

Pune
MAHARASHTRA
411001
India 
Phone  8806049448  
Fax    
Email  nehakamble_84@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  BJGMC and Sassoon General Hospital, Pune  
Address  , BJGMC and Sassoon General Hospital,Jai Prakash Narayan Road, Railway Station Rd, Agarkar Nagar, Pune, Maharashtra 411001 
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 
DrShradha Kulkarni   BJGMC and Sasson General Hospital   Anaesthesia department,3rd floor, 11 storey building, BJGMC and Sasson General Hospital , Jai Prakash Narayan Road, Railway Station Rd, Agarkar Nagar, Pune, Maharashtra 411001
Pune
MAHARASHTRA 
8390911035

shradha.kulkarni113@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE B.J.G.M.C & S.G.H PUNE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient willing to give consent for participation in study
Rib fractures confirmed radiologically
NRS pain score more than four
Spontaneous breathing
More than two rib fractures 
 
ExclusionCriteria 
Details  Infection at block site
Known allergy to local anaesthetic
Known case of or diagnosed case of spinal injury or altered sensorium
Known case of hepatic or renal insufficiency
Diagnosed case of Subcutaneous emphysema
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ultrasound-guided Rhomboid Intercostal and Subserratus Plane Block as a better Analgesic Modality in Acute Rib Fractures  3months 
 
Secondary Outcome  
Outcome  TimePoints 
RISS block is likely to demonstrate a favorable safety profile, with minimal complications, supporting its use as a reliable and minimally invasive analgesic technique in thoracic trauma.  3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/04/2026 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shradha.kulkarni113@gmail.com].

  6. For how long will this data be available start date provided 05-04-2026 and end date provided 05-10-0026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
This observational study titled Ultrasound guided Rhomboid Intercostal and Subserratus Plane Block as an Analgesic Modality in Acute Rib Fractures aims to evaluate the effectiveness of the Rhomboid Intercostal and Subserratus Plane block for pain relief in patients with multiple rib fractures admitted to the trauma intensive care unit. Rib fractures due to thoracic trauma cause severe pain that limits breathing and increases the risk of respiratory complications such as pneumonia. Although systemic analgesics are commonly used, they may not always provide adequate pain relief.
The study proposes the use of an ultrasound guided Rhomboid Intercostal and Subserratus Plane block as a regional analgesic technique for effective chest wall pain control. The aim is to compare the analgesic efficacy of this block with the standard analgesic protocol used in patients with rib fractures. This technique is expected to reduce pain, improve respiratory function, and decrease the need for systemic opioids.
Adult patients with radiologically confirmed rib fractures will be included in the study after obtaining informed consent. Patients receiving the RISS block will be given an ultrasound guided Rhomboid Intercostal and Subserratus Plane block using 0.25 percent bupivacaine 40 ml followed by catheter placement for continuous analgesia along with standard analgesic treatment. Pain will be assessed using the Numeric Rating Scale at multiple time points up to 48 hours both at rest and during coughing. Respiratory function will be evaluated using incentive spirometry and SpO2 FiO2 ratio and total opioid consumption will also be recorded.
The study involves minimal risk and is expected to show that the RISS block provides better pain relief in patients with acute rib fractures. Improved analgesia may reduce opioid requirement improve incentive spirometry performance enhance respiratory function and contribute to better overall recovery in trauma patient
 
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