| CTRI Number |
CTRI/2025/03/081901 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of two blocks thoracic paravertebral block and erector spinae block in multiple rib fracture patients |
|
Scientific Title of Study
|
To compare the analgesic efficacy of continuous infusion of thoracic paravertebral v/s erector spinae block in multiple rib fractures: A prospective randomised controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gaurav |
| Designation |
Junior Resident Department of Anaesthesia |
| Affiliation |
Dr Rajendera Prasad Government Medical Collage Tanda at Kangra |
| Address |
Department of Anaesthesia at Dr RPGMC Tanda at Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9459996855 |
| Fax |
|
| Email |
gaurav.kamring@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Gupta |
| Designation |
Associate Professor Department of Anaesthesia Dr RPGMC Tanda |
| Affiliation |
Dr Rajendra Prasad Government medical college Tanda at Kangra |
| Address |
Department of Anaesthesia at Dr RPGMC Tanda at Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418044928 |
| Fax |
|
| Email |
drbharti203@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Gupta |
| Designation |
Associate Professor Department of Anaesthesia Dr RPGMC Tanda |
| Affiliation |
Dr Rajendra Prasad Government medical college Tanda at Kangra |
| Address |
Department of Anaesthesia at Dr RPGMC Tanda at Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418044928 |
| Fax |
|
| Email |
drbharti203@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Dr RPGMC Tanda at Kangra 176001 |
|
|
Primary Sponsor
|
| Name |
Gaurav |
| Address |
Department of Anaesthesia Dr RPGMC Tanda, Himachal Pradesh, India, 176001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Gaurav |
Dr RPGMC Tanda |
Department of Anaesthesia at DR RPGMC Tanda at Kangra
Kangra
HIMACHAL PRADESH |
9459996855
gaurav.kamring@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC Tanda |
Approved |
|
|
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 |
| Comparator Agent |
USG guided Erector Spinae Block |
USG guided continuous erector spinae block for 48 hrs using 0.2 % Ropivacaine |
| Intervention |
USG guided Thoracic Paravertebral block |
USG guided continuous Thoracic Paravertebral block for 48 hrs using 0.2 % Ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Multiple rib fractures (2or more than 2)
ASA class 1-3
Patients more than 18 years of age and less then 65 years of age
|
|
| ExclusionCriteria |
| Details |
Patient not willing to give consent
Patient with no pain
Patient with bleeding disorder
Wound or infection at site
Hypersensitivity to study drug
Patient with low gcs
Patient with spinal deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the analgesic efficacy and safety of USG guided continuous infusion of thoracic paravertebral block vs erector spinae block in patients with multiple rib fractures |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare pulmonary function and required ventilatory support
To compare haemodynamics before and after the block
Complications related to blocks
Catheter related complications |
1year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gaurav.akmring@gmail.com].
- For how long will this data be available start date provided 06-06-2024 and end date provided 31-12-2025?
Response (Others) - 1/1/2025 to 31 /12/2025
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is to compare the efficacy between Thoracic Paravetebral and Erector Spinae block in multiple ribs fractures patients and heamodynamic stability and duration and complications related to the block |