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CTRI Number  CTRI/2025/06/088491 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 09/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study to assess pain treatments prescribed with the help of a modified rib fracture severity scoring system in chest trauma patients 
Scientific Title of Study   Assessment of an analgesia protocol using a novel modified rib fracture score in patients with blunt chest trauma at a level 1 trauma center in South India 
Trial Acronym  RIBAN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Inba Idhaya A 
Designation  Post graduate registrar 
Affiliation  Christian Medical College 
Address  Department of anaesthesia, Christian Medical College, Vellore -632004, Tamil Nadu, India.

Vellore
TAMIL NADU
632004
India 
Phone  9003622607  
Fax    
Email  idhayainba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrRahul Pillai 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesia, Christian Medical College,Vellore - 632004, Tamil Nadu, India
Christian Medical College,
Vellore
TAMIL NADU
632004
India 
Phone  9894460758  
Fax    
Email  Rahul.pillai@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  DrRahul Pillai 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anaesthesia, Christian Medical College,Vellore - 632004, Tamil Nadu, India
Christian Medical College,
Vellore
TAMIL NADU
632004
India 
Phone  9894460758  
Fax    
Email  Rahul.pillai@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Institutional Fluid Grant, Christian Medical College, Vellore- 632004, Tamil Nadu, India 
 
Primary Sponsor  
Name  Institutional Fluid Grant , Christian Medical College 
Address  Christian Medical College, Vellore-632004, Tamil Nadu, India. 
Type of Sponsor  Private 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 
Dr Inba Idhaya  Christian Medical College  Department of Trauma Surgery/A601/Ranipet campus
Vellore
TAMIL NADU 
09003622607

idhayainba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  radiologically proven rib fracture
blunt mechanism
admitted in ward 
 
ExclusionCriteria 
Details  admitted in ICU or intubated
penetrating mechanism
refusal of consent
pregnant women
head injury or major distracting injury precluding assessment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to assess the efficacy of the novel modified rib fracture score in
selection of an analgesia plan 
patient will be assessed by using PIC score which will look at P-Pain , I-Incentive spirometry,C- Cough which will be monitored daily till the patient discharged , and will be later looking at the trend of the score and assessment will be made 
 
Secondary Outcome  
Outcome  TimePoints 
Patient outcomes: length of hospital stay, in-hospital pneumonia rates, ICU transfer rate
and discharge
Influence of pulmonary contusions, chronic lung disease on the outcomes Confounders: Influence of ISS & AIS as independent predictors on outcomes. 
ISS,AIS will be calculated at the time of admission ,presence of lung contusions will be seen throug CT findings ,at the time of discharge the length of hospital stay will be noted 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/06/2025 
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="2"
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  

Rib fractures, a common occurrence among patients who sustain blunt chest trauma, carry a
significant health burden in terms of morbidity and mortality. The primary pathophysiology is
hypoventilation due to pain. As the literature supports, adequate pain management reduces
pulmonary complications. However, choosing an appropriate pain plan through one of the various
available scoring systems requires further study. We believe that the currently available pain
management algorithms for multiple rib fractures do not adequately address the analgesia needs
of our patients. Therefore, we intend to modify an existing scoring system and then assess the new
score’s efficacy.
To understand what modifications are needed, we conducted Delphi survey among experts in
anesthesiology, trauma surgery, and emergency medicine. Based on their insights and a review of
the literature, we developed an updated scoring system for this study. We aim to evaluate the use
of this novel, indigenously modified rib fracture score in implementing a stratified analgesia
protocol. The effectiveness of this protocol will be assessed using PIC (Pain, Incentive spirometry
volume, cough) score. Additionally, we will assess the rate of common complications of rib
fractures such as pneumonia rates, ICU admissions and length of hospital stay.
 
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