| CTRI Number |
CTRI/2024/01/061719 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To reduce pain in fracture patients by giving local nerve block vs intravenous opiod |
|
Scientific Title of Study
|
To study the utility of ultrasound guided block for analgesia in patients of acute limb injuries presenting to emergency department: a randomized controlled 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 |
Dr. Barada Prasad Debasish Panda |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
AIIMS Emergency Office, Department of Emergency Medicine, All India Institute of Medical Sciences
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
7978005581 |
| Fax |
|
| Email |
bpdp98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room Number-319, Casualty Block, Jay Prakash Narayan Apex Trauma Centre
Safdarjung Enclave
South
DELHI
110029
India |
| Phone |
8518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Barada Prasad Debasish Panda |
| Designation |
Junior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
AIIMS Emergency Office, Department of Emergency Medicine, All India Institute of Medical Sciences
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
7978005581 |
| Fax |
|
| Email |
bpdp98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jay Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar East,
New Delhi,
Delhi-110029 |
| 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 |
| Dr Barada Prasad Debasish Panda |
Jay Prakash Narayan Apex Trauma Center |
Yellow Zone, Casualty Block, Department of Emergency Medicine
South
DELHI |
7978550081
bpdp98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional opiod therapy |
Patients will be given 1 mcg/kg body weight of fentanyl bolus intravenously |
| Intervention |
Site specific nerve block |
Ultrasound guided site specific nerve block according to location of fracture. Nerve block is performed by inserting a nerve block needle under ultrasound guidance and injecting 0.5% bupivacaine and 2% lignocaine (calculated according to body weight) causing local infiltration around nerve leading to pain sensation loss over a period of 6 to 12 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult of both gender from eighteen to eighty years presenting to emergency department with history of trauma and triaged as yellow or green and having upper or lower limb fractures with on arrival pain score greater than or equal to seven and patient or legally authorized representative gives consent |
|
| ExclusionCriteria |
| Details |
Patient or legally authorized representative is unable or unwilling to give consent or red triaged patients or patients with unstable vitals on arrival or less than eighteen years or greater than eighty years or patients with life threatening comorbidities or history of hypersensitivity or known contraindication to local anaesthetics or pain score less than seven |
|
|
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 study and compare the pain score reduction during initial six hours of intervention |
1hour,3hour,6hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the length of emergency department stay |
In hours |
| To study complications of block procedure & compare with complications of opiod usage |
Over 6 hours |
| To study the time taken to reduce the pain after intervention |
In minutes |
| To study the time taken to do the procedure |
In minutes |
| To study the reduction in opiod usage due to block procedure |
Over 6 hours |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/02/2024 |
| 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="0"
Months="6"
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
|
In patients of traumatic fractures presenting with severe pain usually intravenous fentanyl or morphine is given. But these opiods have their own share of problems including respiratory depression, hypotension and future addiction.
So in this study we are comparing efficacy of blocking the nerve supplying the fracture area using local anaesthetic agents in reducing pain over a period of six hours with respect to intravenous fentanyl.
This nerve block strategy is already being used in operation theatre. But in this study we are trying to utilise this technique in emergency department in traumatic fracture patients.
This study is a prospective, open label, randomized control trial of parallel groups to compare efficacy of site specific nerve block versus conventional opiod therapy in traumatic fracture patients in successfully alleviating pain in an emergency department. Patients presenting to emergency department after traumatic fractures, giving consent, meeting inclusion and exclusion criterion are randomized into intervention group of nerve block versus control group of intravenous fentanyl. The procedure is done ultrasound guided and time is noted. The pain scores are noted at 1 hour, 3 hours and 6 hours of procedure. Then both pain scores are compared as the primary outcome. In secondary outcome we would study total duration of emergency department stay and whether intervention is reducing the stay, total time taken to do the intervention, study and compare the complications in both groups and reduction in opiod dose by nerve block in 6 hours period. |