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
|
|
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
|
|
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. |