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CTRI Number  CTRI/2024/04/065274 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study on nerve blocks versus intravenous analgesics for patients with closed chest trauma. 
Scientific Title of Study   Analyzing the efficacy of chest block in comparison with intravenous analgesia for acute pain management in closed chest trauma with a Numeric rating scale (NRS) score of 7 or more, presenting to the Emergency department - A Prospective Pragmatic Interventional study. 
Trial Acronym  CBT2(Chest Block – Thoracic Trauma) trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gokul Prakash 
Designation  Senior House Officer 
Affiliation  Christian Medical College and Hospital 
Address  Department of Emergency Medicine, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9442624688  
Fax    
Email  gokulprakashsvks96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sandeep Nathanael David 
Designation  Assistant Professor 
Affiliation  Christian Medical College and Hospital 
Address  Department of Emergency Medicine, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8072149396  
Fax    
Email  sanada_124@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Nathanael David 
Designation  Assistant Professor 
Affiliation  Christian Medical College and Hospital 
Address  Department of Emergency Medicine, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8072149396  
Fax    
Email  sanada_124@yahoo.com  
 
Source of Monetary or Material Support  
Internal - Fluid Research Grant, Christian Medical College,Vellore , Tamil Nadu ,India - 632 004 
 
Primary Sponsor  
Name  Christian Medical College Internal Fluid Research Grant 
Address  Christian Medical College, Vellore , Tamil Nadu , India 632004  
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 Sandeep Nathanael David  Christian Medical College  Trauma Bay, Department of Emergency Medicine, Christian Medical College,Vellore 632004
Vellore
TAMIL NADU 
8072149396

sanada_124@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Research Institutional Review Board  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 
Comparator Agent  Intravenous analgesia  Round the clock IV Morphine as per ED protocol and ED physician’s discretion 
Intervention  Ultrasound guided plane blocks  The erector spinae plane block or serratus anterior plane block under ultrasound guidance using 20-40 ml 0.2% Ropivacaine within one hour of diagnosis. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult patients with blunt thoracic traumas with 2 or more radiologically confirmed rib fractures. 
 
ExclusionCriteria 
Details  1. Patient does not give consent.
2. Open chest wounds.
3. Polytraumatised patients
4. Patients who are haemodynamically unstable or require ICU care
5. Allergy or contraindications to NSAIDs/Paracetamol/Local anaesthetics
6. Contraindications to block (coagulopathy, overlying skin infection).
7. Pregnant women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain score   Reduction in pain score from 7 to less than 4, or by more than 50% from time of patient admission in the emergency department till discharge from emergency department, or till 12 hours in the ward.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Success rate of the block in reducing the pain score
2.Compraison of patient satisfaction.
3.Incidence of adverse effect on either side of the arm
4.Reduction in rescue analgesia
 
1.Success rate(50% reduction in score or absolute value less than 4)of the block.
2.Comparing patient satisfaction between 2 arms at the time of discharge or admission using study proforma
3.Incidence of adverse events such as allergic reaction, hypotension, nausea/vomiting, pneumo/hemothorax, hematoma & injection site infection.
4.Compare the time of resuce analgesia & the need of repeated analgesia from ED admission to ED discharge/ 12hrs in ward .
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 3 
Date of First Enrollment (India)   01/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

    Patients who present to the emergency department (ED) with blunt thoracic trauma are usually managed  with intravenous analgesia including NSAIDS and opioids. Rib fractures are extremely painful and can lead to poor respiratory effort and hypoxia from thoracic splinting. Opioid and non-opioid analgesia often do not provide sufficient or consistent analgesia and may require doses where the adverse effects are more compared to the benefits especially in the elderly population or those with comorbidities such as obesity or reactive airway disease. Many patients in our ED receive a chest block which seems to provide sufficient and long lasting analgesia. Since the blocks are administered by only a few trained personnel in the department presently, many patients do not receive the blocks. In our study we wish to compare the analgesia and improvement in respiratory function between patients who receive a block and those who receive the standard analgesic management.. The analgesia achieved will be objectively scored by the numerical rating scale or visual analogue scale. Improvement in the respiratory function will be assessed with the change in tidal volumes on incentive spirometry. We will also look at success rates of performing these blocks in the emergency department setting by consultants trained to administer the blocks, as well as the average duration of action of the block.

 
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