| CTRI Number |
CTRI/2022/08/044541 [Registered on: 01/08/2022] Trial Registered Prospectively |
| Last Modified On: |
18/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between efficacy of analgesia produced by intravenous analgesics and ultrasound guided peripheral nerve block among acute extremity trauma victims |
|
Scientific Title of Study
|
Comparison between Efficacy of Analgesia Produced by Intravenous Analgesics and Ultrasound Guided Peripheral Nerve Block among Isolated Single Extremity Trauma patients in Emergency Department; An Exploratory Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agniva Mukhopadhyay |
| Designation |
MCh SR |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Trauma Center
Dept. of Trauma Surgery & Critical Care
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09874768358 |
| Fax |
|
| Email |
agniva220@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Trauma Center, Dept of Trauma Surgery & Critical Care
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09874768358 |
| Fax |
|
| Email |
doc.ajaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Agniva Mukhopadhyay |
| Designation |
MCh SR |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Trauma Center
Dept. of Trauma Surgery & Critical Care
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09874768358 |
| Fax |
|
| Email |
agniva220@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, Virbhadra Road, ShivajiNagar, Rishikesh, Dist:Dehradun, PIN: 249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Virbhadra Road, Rishikesh, 249203 |
| 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 |
| Agniva Mukhopadhyay |
Trauma Center Emergency (Area 413), Dept of Trauma Surgery & Critical Care, AIIMS RIshikesh |
AIIMS Rishikesh, Virbhadra Road, Rishikesh, 249203
Dehradun
UTTARANCHAL |
9874768358
agniva220@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: T07-T07||Injuries involving multiple body regions, (2) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous analgesia will be given |
Intravenous analgesia will be provided with IV acetaminophen(15mg/kg 6hrly) and IV tramadol (1mg/kg 8th hourly) to the included patients. |
| Intervention |
ultrasound guided peripheral nerve block |
ultrasound guided peripheral nerve blocks will be given to included patients as per level of injury. Inj Bupivacaine 0.25% will be provided at a dose of 0.3ml/kg and when 2 nerves involved bupivacaine 0.25% will be provided at a dose of 0.6ml/kg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years to 70years of age will be included |
|
| ExclusionCriteria |
| Details |
patients with polytrauma
patients with hemodynamic instability
patients with associated GCS<15
patients not willing/not able to give consent
patients with a known allergic reactions to local anesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome in both groups will be measured using NRS score. Calculation of NRS score will be started 30min after the intervention (nerve block/IV analgesics) and then will be continued every hour till patient stay in ED |
Primary outcome in both groups will be measured using NRS score. Calculation of NRS score will be started 30min after the intervention (nerve block/IV analgesics) and then will be continued every hour till patient stay in ED |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
 Patient satisfaction (will be calculated using 5 point Likert scale) at the end of ED stay
 Length of hospital stay
 Changes in any vitals during ED stay
 Definite procedure (operative/non operative)
 Final outcome (discharge/death/referral/LAMA)
|
above points will be considered for monitoring of secondary outcome |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/08/2022 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not submitted for any publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pain is the most common complaint in a trauma emergency department. In a busy trauma ED pain management is often neglected i/v/o more life threatening injuries; however, untreated/poorly treated pain can result in complications like PTSD later on, at the same time stress response to significant pain might increase patient’s morbidity. The use of peripheral nerve block as a potent mode of anesthesia and analgesia is well approved and quite frequent among anesthetists inside OT. Pain management in trauma ED has been conventionally done with IV analgesics (Paracetamol, opioids, NSAIDs). Often, some of these drugs are contraindicated in a polytrauma patient (eg: opioids should be used cautiously in head injury patients). The use of peripheral nerve block for analgesia in trauma ED is an area yet to be adequately explored. Through this study, we are trying to establish a new pain management protocol for acute trauma victims for better patient satisfaction. Acute trauma patients coming to trauma emergency will be first managed as per ATLS protocol and then will be evaluated based one of inclusion and exclusion criteria. Randomization will be then done and after informed consent patients will be treated with conventional IV analgesics(Inj Paracetamol 1gm IV 6th hourly with Inj Tramadol 15mg/kg 8th hourly)/peripheral nerve block (Inj Bupivacaine 0.25% @ 0.3ml/kg). The efficacy of analgesia will be compared using NRS (Numeric Rating Score) hourly along with other parameters like vitals, adverse effects of used medications, patient satisfaction etc. There are some studies proving the efficacy of peripheral nerve block over IV analgesics in trauma emergency, however, as per the author’s knowledge, no Indian study has been done in this regard so far. So this study will help in developa ing new pain management protocol for better patient management as well as satisfaction. |