| CTRI Number |
CTRI/2025/05/087403 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of intravenous lignocaine and opoid on polytrauma patients admitted in ICU and effect of both on their inflammation status,and other blood biomarkers and their side effects |
|
Scientific Title of Study
|
Assessment of effects of iv lignocaine with IV OPOIDS vs IV opoid PLAIN over polytRauma stress response
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivam Rai |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Anaesthesia, GSVM Medical College ,Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9455623448 |
| Fax |
|
| Email |
shivampersonal77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Kumar Verma |
| Designation |
Professor |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Anaesthesia ,GSVM Medical College ,Swaroop Nagar,Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9336107410 |
| Fax |
|
| Email |
anil_16021976@rediffmail.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shivam Rai |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Anaesthesia,GSVM Medical College ,Swaroop Nagar,Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9455623448 |
| Fax |
|
| Email |
shivampersonal77@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical College, Swaroop Nagar ,Kanpur ,Uttar Pradesh,India ,Pincode:208002 |
|
|
Primary Sponsor
|
| Name |
Shivam Rai |
| Address |
Department of Anaesthesia,LLR Hospital ,GSVM Medical College ,Kanpur,India , Pincode:208002 |
| 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 Shivam rai |
Lala Lajpat Rai Hospital |
Department OF Anaesthesia,LLR Hospital ,GSVM Medical College
Kanpur Nagar
UTTAR PRADESH |
9455623448
shivampersonal77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSVM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R068||Other abnormalities of breathing, (2) ICD-10 Condition: R068||Other abnormalities of breathing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iv Fentanyl |
IV Fentanyl infusion at a dose of 0.7 mcg/kg/hr .Total duration till 36 hours from start of the infusion. |
| Intervention |
IV Lignocaine with iv Fentanyl |
lignocaine 1.5 mg followed by IV
lignocaine infusion in a dose of 1.5mg/kg/hr and dose reduction by 50% every 8
hrly. After 8 hrs we will reduce dose to 1mg/kg/hr and at 16 hr to 0.5 mg/kg/hr and
we will also monitoring signs and symptoms of systemic toxicity I.e hemodynamic
instability, arryhthmia and heart blocks, neurological symptoms i.e seizures and
blood investigations Such as Sr.creatinine and BUN. The total duration of Intervention is till 36 hours from start of infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 85 years
informed written consent
A person who has suffered multiple traumatic injury in their body as a result of single event |
|
| ExclusionCriteria |
| Details |
Patient with relevant drug allergy
Patient with opoid dependence
Patients who refused to participate in studies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
effects of IV lignocaine combined with IV opioids compared to IV
opioids alone on the physiological and biochemical stress (e.g., IL-6,
LDH)response in polytrauma patients |
0H HOURS, 8 HOURS ,24 HOURS, 36 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain Control: Whether IV Lignocaine provides superior analgesia compared to opioid-only treatment.
2.Opioid Consumption: Whether IV Lignocaine reduces opioid requirements, thereby minimizing opioid-related side effects.
|
from time of admission till 36 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="30"
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)
|
01/06/2025 |
| 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 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 - NO
|
|
Brief Summary
|
This randomized prospective study evaluates the effect of IV lignocaine combined with IV opioids versus IV opioids alone on stress response in polytrauma patients. Conducted at GSVM Medical College, it measures biomarkers such as IL-6, LDH, serum lactate, D-dimer, and SOFA score to assess pain and inflammation. Patients are monitored over 36 hours to observe hemodynamic stability, toxicity, and analgesic efficacy, aiming to establish improved multimodal pain management protocols. |