| CTRI Number |
CTRI/2025/12/099362 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided nerve blocks compared with intravenous opioids for acute pain relief in upper and lower limb trauma patients presenting to the emergency department |
|
Scientific Title of Study
|
A comparison of ultrasound guided peripheral nerve blocks and intravenous opioids for acute pain relief in acute limb injuries presenting to emergency department |
| Trial Acronym |
Relief trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay G Karlattimatt |
| Designation |
DNB resident |
| Affiliation |
Shija hospitals and research institute |
| Address |
Emergency department,Shija hospitals and research institute langol imphal west , Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7619432274 |
| Fax |
|
| Email |
sanjaygkm666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Momin |
| Designation |
Senior consultant |
| Affiliation |
Shija hospitals and research institute |
| Address |
Anesthesia consultants room ,first floor , doctors lounge ,Shija hospitals and research institute Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
8731085220 |
| Fax |
|
| Email |
Kajalmomin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay G Karlattimatt |
| Designation |
DNB resident |
| Affiliation |
Shija hospitals and research institute |
| Address |
Emergency department,Shija hospitals and research institute langol , imphal west
MANIPUR
795004
India |
| Phone |
7619432274 |
| Fax |
|
| Email |
sanjaygkm666@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shija hospitals and research institute |
| Address |
shija hospitals and research institute , Imphal west , Manipur 795004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| sanjay G Karlattimatt |
shija hospitals and research institute |
Trauma intervention room , Emergency department, red zone
Imphal West
MANIPUR |
7619432274
sanjaygkm666@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical comittee, SAHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous opioids for pain relief |
Intravenous opioids will be used as a comparator for acute limb injuries in this study |
| Intervention |
Nerve block |
Ultrasound guided peripheral nerve block axilary for upper limb followed by PENG for lower limb injuries |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
upper and lower limb trauma , moderate to severe pain on NRS more than 4, time of presentation to ED within 6 to 12 hours of injury or trauma |
|
| ExclusionCriteria |
| Details |
open fractures and trauma in association with significant neuromuscular injury ,signs of compartment syndrome, significant head trauma where immediate surgery is planned, contraindications for nerve block, who refuse to undergo the procedure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine the efficacy of ultrasound guided nerve blocks versus intravenous opioids for acute pain relief in ED |
The patient will be assessed at 30,60 , 120 minutes post intervention for pain relief and possible any side effects of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in pain scores after intervention , to compare the time to adequate pain relief between the two groups |
30 , 60 , 120 minutes post intervention |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
26/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
pain management in acute trauma is critical for improving patient comfort, facilitating diagnostic evaluation and preventing complications. IV opioids have traditionally been the mainstay of acute pain relief , but they are associated with significant side effects such as respiratory depression , nausea and sedation. Peripheral nerve blocks particularly when guided through ultrasound offer targeted pain management with fewer systemic side effects this thesis explores and compares the effectiveness of intravenous opioids versus ultrasound guided nerve blocks in the management of pain in patients with upper and lower limb trauma |