| CTRI Number |
CTRI/2022/03/040711 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
28/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check analgesic efficacy of erector spinae plane block in patients having multiple rib fractures |
|
Scientific Title of Study
|
To assess analgesic efficacy of erector spinae plane block in patients with multiple 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 Renu Bala |
| Designation |
Professor |
| Affiliation |
PT. B.D. Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and critical care, 2nd Floor,New OT Complex Building,PT. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8901322251 |
| Fax |
|
| Email |
neurodmrenu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshay Bhalla |
| Designation |
Postgraduate student |
| Affiliation |
Pt. B.D. Sharma PGIMS,Rohtak. |
| Address |
Department of Anaesthesiology and critical care,2nd Floor, New OT complex building,Pt. B.D. Sharma PGIMS, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
8295059297 |
| Fax |
|
| Email |
bhalla.lakshay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshay Bhalla |
| Designation |
Postgraduate student |
| Affiliation |
Pt. B.D. Sharma PGIMS,Rohtak. |
| Address |
Department of Anaesthesiology and critical care,2nd Floor, New OT Complex Building,Pt. B.D. Sharma PGIMS, Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
8295059297 |
| Fax |
|
| Email |
bhalla.lakshay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS,
Rohtak, Haryana. PIN code - 124001 |
|
|
Primary Sponsor
|
| Name |
Deapartment of Anaesthesiology and critical care |
| Address |
Pt. B.D. Sharma PGIMS,Rohtak. |
| Type of Sponsor |
Government 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 Lakshay Bhalla |
Pt. B.D. Sharma PGIMS Rohtak. |
New ICU,Ist Floor , New OT Complex Building, Pt. B.D. Sharma PGIMS, Rohtak
Rohtak
HARYANA |
8295059297
bhalla.lakshay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committe,Pt. B.D. Sharma PGIMS,UHS,Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S224||Multiple fractures of ribs, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
To assess analgesic efficacy of erector spinae plane block in patients with multiple rib fractures |
To assess analgesic efficacy of erector spinae plane block in patients with multiple rib fractures. Patients will be given a bolus of 20 ml 0.25% ropivacaine by means of ultrasound guided erector spinae plane block , a continuous catheter will be kept insitu in the plane for 3 days and ropivacaine infusion will be started at the rate of 4mm/hr to 8ml/hr depending upon VAS score( to be kept below 4).Haemodynamic parameters, pain at rest and at coughing after block half hourly till 3hrs thereafter 6hrly for 3days will be observed. Pulmonary function tests tests , arterial blood gas analysis, oxygenation 6hrs after block , thereafter 24hrly for 3 days will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, having unilateral rib fractures (more than 2) admitted to Intensive care unit will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
Patients having bilateral rib fractures
Associated injuries of pelvis/abdomen/head
patients having altered consciousness
Requiring mechanical ventilation
BMI > 30 kg/m2
History of drug abuse/chronic alcoholism
altered bleeding or coagulation profile
allergy to local anaesthetic
presence of infection/wound at the injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain as per VAS score
Analgesic requirements |
Baseline, Vas score 1/2 hrly for 3 hours after block and thereafter 6hrly for 3 days, analgesic requirement 12 hrly for 3 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulmonary function tests
haemodynamic parameters |
Pulmonary function test 6 hrs from block and thereafter 24 hrly, Haemodynamic parameters 1/2 hrly for 3 hrs from block and thereafter 6 hrly for 3 days |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|