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CTRI Number  CTRI/2020/12/030123 [Registered on: 30/12/2020] Trial Registered Prospectively
Last Modified On: 08/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective Observational 
Study Design  Single Arm Study 
Public Title of Study   Utility of Ultrasound Guided Erector Spinae Plane Block in for Rib Fractures in the Emergency Department 
Scientific Title of Study   Utility of Ultrasound Guided Erector Spinae Plane Block in Patients Presenting to the Emergency Department with Rib Fractures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhu Srinivasarangan 
Designation  Assistant Professor 
Affiliation  JSS Medical College, JSS Academy of Higher Education and Research 
Address  Department of Emergency Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru.

Mysore
KARNATAKA
570004
India 
Phone  9449813976  
Fax    
Email  madhu@jssuni.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akkamahadevi P 
Designation  Professor 
Affiliation  JSS Medical College, JSS Academy of Higher Education and Research 
Address  Department of Anaesthesia, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru.

Mysore
KARNATAKA
570004
India 
Phone  7406784848  
Fax    
Email  emergencymedicinejss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijith Sivasankar 
Designation  Resident 
Affiliation  JSS Medical College, JSS Academy of Higher Education and Research 
Address  Department of Emergency Medicine, JSS Medical College, JSS Academy of Higher Education and Research, Mysuru.

Mysore
KARNATAKA
570004
India 
Phone  7760947519  
Fax    
Email  abhijith92ledger@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, Karnataka. 570004. 
 
Primary Sponsor  
Name  JSS Medical College 
Address  JSS Medical College, JSS Academy of Higher Education and Research, Mysuru, Karnataka. 570004. 
Type of Sponsor  Research institution and hospital 
 
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 Abhijith Sivasankar  Department of Emergency Medicine, JSS Hospital, Mysuru.  Department of Emergency Medicine, JSS Hospital, M.G. Road, Mysuru. 570004.
Mysore
KARNATAKA 
7760947519

abhijith92ledger@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, JSS Medical College.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S224||Multiple fractures of ribs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients presenting to emergency medicine department with
• Age>18 years.
• Patients with unilateral, multiple (2 or more) rib fractures and moderate to severe pain (NRS 4 to 10) measured on a self-reported NRS.
• Normal lower extremity neurovascular examinations.
• Having undergone an USG guided Erector Spinae Plane Block.
 
 
ExclusionCriteria 
Details  • In-patients shifted from other hospital for elective procedure and continued care.
• Patients who received opioid analgesia within 30 mins prior to presenting to ED.
• Patients with altered pain perception – unconscious patients, severe head injury.
• Known international normalized ratio (INR) > 3.0, prior history of bleeding diathesis.
• Known hypersensitivity to local anaesthetics or Bupivacaine.
• Pregnant patients (positive urine or serum B-HCG).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To determine the effectiveness of an Ultrasound (USG) guided Erector Spinae Plane Block (ESPB) in ameliorating pain and improving lung function in patients presenting to the ED with multiple rib fractures.   48 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
2. To assess the safety and the feasibility of the ESPB in the ED.  48 hours 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/01/2021 
Date of Study Completion (India) 06/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Context: Alleviating significant pain and enhancing lung function in patients with multiple rib fractures presents a formidable challenge to all Emergency Physicians (EP). Conventional pharmacological measures and traditional thoracic regional analgesia techniques are not always feasible or safe in the Emergency Department (ED). Therefore, an effective, feasible and safe method for providing analgesia in such patients will be extremely advantageous to all patients and Emergency Physicians alike. Here in this study, we aim to ascertain the utility of a regional myofascial block technique that can be applied in patients suffering from multiple rib fractures in the ED.

AIMS:

1.       To determine the effectiveness of an Ultrasound (USG) guided Erector Spinae Plane Block (ESPB) in ameliorating pain and improving lung function in patients presenting to the ED with multiple rib fractures.

2.       To assess the safety and the feasibility of the ESPB in the ED.

Setting and Design: A retrospective observational clinical study will be conducted in the ED of a tertiary care hospital over a period of 12 months.

Methods and Material: Data regarding all patients with rib fractures who had undergone an Erector Spinae Plane Block in the ED will be extracted from the Emergency Department Procedure Register and the In-Patient Case Sheets will be obtained from the Medical Records Department for review and analysis. The data shall include, but will not be limited to, the Numeric Rating Scale of pain and respiratory parameters i.e. Respiratory Rate and PEFR at 30 minutes post procedure and subsequently after every top-up dose, up to a period of 48 hours.

Statistical Analysis: Descriptive statistics like Mean, Standard deviation, Frequency and Percentage shall be used. Inferential statistics like Repeated Measure Anova shall be done using SPSS software version 22, (IBM).

Results: The mean NRS was significantly reduced by >50% at 30 minutes and by 72% over a 48 hour period (p<0.001). Meaningful improvements in the respiratory parameters were also observed during the same period with significant increments in the PEFR values [49% increase (p<0.001)] as well as a decrease of 36% in the Respiratory Rate (p<0.001). The mean time for performing the procedure was 16.27 minutes and no adverse events were observed as a consequence of the block.

Conclusion: The study demonstrates the efficacy of USG guided ESPB in ameliorating pain as well as improving lung function for multiple rib fracture patients. This procedure can be performed in a short time making it suitable for application in the Emergency Department. No adverse events as a consequence of the ESPB were noted.

Key words: Rib Fractures, Erector Spinae Plane Block, Ultrasound, Emergency Department, NRS, Respiratory Parameters.


 
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