| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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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