| CTRI Number |
CTRI/2019/04/018543 [Registered on: 10/04/2019] Trial Registered Prospectively |
| Last Modified On: |
09/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two regional anesthetic techniques for pain relief in patients with rib fractures |
|
Scientific Title of Study
|
Comparison of Thoracic Epidural and Erector Spinae Plane block for analgesia following multiple rib fractures: A Randomized open label trial |
| Trial Acronym |
E/E study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RASHMI SYAL |
| Designation |
Senior Resident |
| Affiliation |
AIIMS , Jodhpur |
| Address |
Third Floor OT complex, OPD Block, AIIMS,Basni , 2nd Floor Jodhpur
Third Floor OT complex, OPD Block, AIIMS,Basni , 2nd Floor Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8933060385 |
| Fax |
|
| Email |
rashmisyal2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RASHMI SYAL |
| Designation |
Senior Resident |
| Affiliation |
All india Institute of Medical Sciencesu |
| Address |
Third Floor OT complex, OPD Block, AIIMS,Basni , 2nd Floor Jodhpur
Third Floor OT complex, OPD Block, AIIMS,Basni , 2nd Floor Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
8933060385 |
| Fax |
|
| Email |
rashmisyal2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RASHMI SYAL |
| Designation |
Senior Resident |
| Affiliation |
All india Institute of Medical Sciencesu |
| Address |
Third Floor OT complex, OPD Block, AIIMS,Basni , 2nd Floor Jodhpur
Third Floor OT complex, OPD Block, AIIMS,Basni , 2nd Floor Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8933060385 |
| Fax |
|
| Email |
rashmisyal2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
|
|
Primary Sponsor
|
| Name |
ALL INSTITUTE OF MEDICAL SCIENCES JODHPUR |
| Address |
BASNI JODHPUR |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RASHMI SYAL |
3RD FLOOR, OT COMPLEX, ANESTHESIA AND CRITICAL CARE
AIIMS JODHPUR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RASHMI SYAL |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
OT COMPLEX, THIRD FLOOR, OPD BUILDING, AIIMS, JODHPUR, Basni 2ND PHASE
Jodhpur
RAJASTHAN |
8933060385
rashmisyal2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
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 |
EPIDURAL |
epidural catheter is placed in approximate middle of fractured ribs |
| Intervention |
Erector spinare block |
Erector Spinae block is given in approximate middle of fractured ribs and catheter is placed for 96 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
having multiple rib fractures (2 or more ribs) with VAS score more than 4 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Unconscious patients
3. Open wound/ Pre-existing infection at the site of needle insertion
4. Coagulation Disorders
5. Bilateral rib fractures
6. Severe traumatic brain /spinal cord injury
7. Patient who are intubated /on mechanical ventilation
8. Patient with shock
9. History of abdominal organ injury
10. Patients with renal disorders
11. History of psychiatric illness and pre-existing neurological deficits
12. Known allergy to study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess analgesia by VAS score in post procedure period for 96 hours |
96 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome will be to assess and compare
 Inspiratory capacity(IC) by Coach’s Spirometer
 Arterial blood gases (PaO2, PaCO2)
 Forced and slow vital capacities
 Amount of rescue analgesia required in the study period
 The level of motor blockade if any
 Incidence of any procedure related complications.
|
96 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
14/04/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet planned |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients will be randomly allocated into two groups in 1:1 allocation ratio using computer-generated random numbers. Simple random sequence will be generated from the computer. The group allocation numbers will be concealed in sealed opaque envelopes that will be opened just before the performance of block. Group1 patients will receive TE, whereas Group 2 patients will receive ESP block on the affected side. In the procedure room, routine monitoring including continuous electrocardiography (ECG), non-invasive blood pressure (NIBP) and peripheral oxygen saturation (SpO2) will be attached and baseline vitals will be recorded. All the patients will receive premedication with intravenous (IV) fentanyl 1µg/kg. |