| CTRI Number |
CTRI/2024/05/067819 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Novel Pain Management technique- ultrasound guided anaesthesia injection for rib fractures
|
|
Scientific Title of Study
|
Serratus Anterior Plane Block for Multiple rib fractures-a Novel Pain Management technique
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Vincent |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Basement 2, room 3
Department of Anaesthesiology
Father Muller Medical College
Kankanady
Mangalore
Father Muller Road
Kankanady
mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971023187 |
| Fax |
|
| Email |
djrexvin@fathermuller.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Vincent |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Basement 2, room 3
Department of Anaesthesiology
Father Muller Medical College
Kankanady
Mangalore
Father Muller Road
Kankanady
mangalore
KARNATAKA
575002
India |
| Phone |
8971023187 |
| Fax |
|
| Email |
djrexvin@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Vincent |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Basement 2, room 3
Department of Anaesthesiology
Father Muller Medical College
Kankanady
Mangalore
Father Muller Road
Kankanady
mangalore
KARNATAKA
575002
India |
| Phone |
8971023187 |
| Fax |
|
| Email |
djrexvin@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Charitable Institutions
Kankanady
Mangalore 575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller Charitable Institutions |
| Address |
Father Muller Medical College road, Kankanady
Mangalore
575002 |
| 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 |
| Divya Vincent |
Father Muller Medical College |
Father Muller Medical College road, Kankandy 575002
Mangalore
575002
Dakshina Kannada
KARNATAKA |
8971023187
djrexvin@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Serratus Anterior Block |
Injection of local Anaesthetic in the Plane mentioned above 20 ml of 0.25% bupivacaine one dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Multiple rib fractures
2.American Society of Anaesthesiologists physical status I-IV
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patients with significant neurological or respiratory diseases
3. Patients with BMI more than 40
4. Local anesthetic allergy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in pain scores |
2 hours and 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in ventilation |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
12/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
Response - NO
|
|
Brief Summary
|
Ultrasound-guided Serratus Anterior Plane Block (SAPB) is a newer technique- regional anaesthetic technique first described in 2013 by Blanco and colleagues7 for surgery performed on the anterolateral chest wall, serratus plane blocks aim to provide anaesthesia of the hemithorax SAPB is a single shot block that is relatively easier to administer, does not require elaborate patient positioning , can be learnt easily and done in the emergency department and emergency operation theatres. Here we aim to use SAPB to provide localised pain relief that can last for upto 48 hours. If given in the acute phase of pain, it can improve pulmonary function and provide excellent pain relief that may not be possible with other methods.
|