| 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
|
|
|
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
|
|
|
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. |