| CTRI Number |
CTRI/2024/12/078214 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Erector spinae block on IL-1 beta IL-6 and TNF-alpha and serum cortisol in traumatic spine surgeries |
|
Scientific Title of Study
|
The effect of erector spinae block on inflammatory mediators and stress hormone in traumatic spine surgeries Randomised prospective control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumita Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Anaesthesiology Institute of Medical sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765514029 |
| Fax |
|
| Email |
drsumita.1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Urvashi Anand |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8789172374 |
| Fax |
|
| Email |
uanand425@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumita Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Anaesthesiology intitute of Medical sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765514029 |
| Fax |
|
| Email |
drsumita.1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Institue of Medical sciences Banaras Hindu University Varanasi |
| Address |
Department of Anaesthesiology Institute of Medical sciences Banaras Hindu University Varanasi |
| 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 Sumita Kumari |
Institute Of Medical Sciences Banaras Hindu University |
Department of Anaesthesiology Institute Of Medical Sciences Banaras Hindu University Varanasi -221005
Varanasi
UTTAR PRADESH |
08765514029
drsumita.1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S249||Injury of unspecified nerve of thorax, (2) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae block |
To the patients in trial group E bilateral Erector spinae block will be given under ultrasound guidance with 20mL 0.2 percent Ropivacaine |
| Comparator Agent |
No Block given |
Intravenous Paracetamol(15-20mg/kg) with tramadol(1-2mg/kg) will be given stat intraoperatively half hour before completion of surgery instead of bilateral Erector spinae block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Includes those undergoing traumatic Thoracolumbar spine surgeries belonging to American society of anaesthesiologists physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Age more than 60 or less than 18
Patient with uncontrolled hypertension diabetes mellitus immunological disorders
Patients having allergy to any of the drugs administered
Obesity with BMI more than 30 kg per metre squared |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Erector spinae block on inflammatory mediators IL-1beta, IL-6 and TNF-alpha and serum cortisol levels |
Parameters to be checked immediately post extubation, after 24 hours, 48 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Erector spinae block on perioperative hemodynamics & post operative pain-VAS score |
Perioperative hemodynamics -baseline, After 15 minutes 30 minutes, 45 minutes, 60 minutes, 75 minutes
VAS SCORE- 1 Hour, 2 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 4 |
|
Date of First Enrollment (India)
|
13/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
In this study we aim to
determine the effect of erector spinae block on inflammatory mediators and
stress hormone in traumatic spine surgeries;to
study and compare peri-operative hemodynamic parameters; to assess post-operative pain;to note complications, if any. We
aim to establish the effect of erector spinae block on inflammatory markers (
IL-1β, IL-6, TNF-α) and serum cortisol levels
post operatively in traumatic spinal injury patients undergoing surgery and its further impact on peri-operative hemodynamic parameters, post operative
pain and safety outcome and patient satisfaction. |