| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shradha.kulkarni113@gmail.com].
- 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.
- 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 |