| CTRI Number |
CTRI/2025/09/094089 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Analgesia] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain reduction with hematoma block in patients with clavicle fracture |
|
Scientific Title of Study
|
Effect of Ultrasound-Guided Hematoma Block Versus Intravenous Opioids on Pain Reduction in Patients with Clavicle Fracture: A Prospective Parallel-Group Open-label Randomised 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 |
Sanjeev Kumar Bhoi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Emergency medicine, JPNATC, AIIMS, New Delhi
110029
AIIMS, New Delhi
Ansari Nagar
110029
South
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Kumar Bhoi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Emergency medicine, JPNATC, AIIMS, New Delhi
110029
AIIMS, New Delhi
Ansari Nagar
110029
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev Kumar Bhoi |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Emergency medicine, JPNATC, AIIMS, New Delhi
110029
AIIMS, New Delhi
Ansari Nagar
110029
DELHI
110029
India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India
Pin code: 110029 |
|
|
Primary Sponsor
|
| Name |
Sanjeev Kumar Bhoi |
| Address |
Department of Emergency Medicine,JPNATC
AIIMS, New Delhi
Ansari Nagar
110029 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Abhiraj R |
Department of Emergency Medicine, AIIMS, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sanjeev Kumar Bhoi |
All India Institute of Medical Sciences, New Delhi |
Department of Emergency Medicine
Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi, India
110029
South
DELHI |
08527050391
sanjeevbhoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee, AIIMS, 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 |
Intravenous Opioids (IVO) |
IV fentanyl at a dose of 1 mcg/kg (max 50 mcg) will be given. |
| Intervention |
Ultrasound Guided Hematoma Block (UGHB) |
High frequency linear probe will be used to inject 5 ml of 1 percent Lidocaine and 5 ml of 0.25 percent Ropivacaine into fracture hematoma. 21 or 23 Guage needle will be used in in-plane method to inject the drugs. The procedure will be done once and will not be repeated for the same patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with acute clavicle fracture (within 24 hours of injury).
Radiologically confirmed clavicle fracture.
Defence and Veterans Pain Rating Scale (DVPRS) pain score of 7 or more on arrival.
Ability to provide informed written consent.
|
|
| ExclusionCriteria |
| Details |
Known allergy to local anesthetics or opioids.
Hemodynamic instability (SBP less than 90 mmHg or HR more than 130 bpm).
Polytrauma requiring immediate surgical interventions.
Fractures with neurovascular compromise.
Open clavicle fractures.
History of substance abuse or chronic opioid use.
Cognitive impairment or psychiatric illness. interfering with consent or communication
Local infection or overlying skin lesions at the proposed injection site.
Pregnancy or breastfeeding.
Those who do not give consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 50 percent reduction in pain score (DVPRS 0–10) at 30 minutes post-intervention |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DVPRS scores at 15, 30, 60, and 120 minutes post-intervention |
15, 30, 60, and 120 minutes |
| Requirement for rescue analgesia (defined as DVPRS score of 7 or more at 30 min) |
30 minutes |
| Incidence of side effects: nausea, vomiting, sedation, respiratory depression, allergic reactions, local anaesthetic systemic toxicity or any other. |
120 minutes |
| Time taken to perform Hematoma block (excluding scanning and preparation time) |
|
| Patient satisfaction score at 2 hours (Likert scale 1–5) |
120 minutes |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/10/2025 |
| 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="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
|
While IV opioids are an entrenched standard of care, their side effects and delayed onset of action warrant exploration of more effective and safer alternatives. UGHB offers a promising approach to pain management that is both targeted and minimally invasive. To date, there are limited prospective studies comparing UGHB with IV opioids specifically for clavicle fractures in the emergency setting. This study seeks to fill that gap by conducting a randomized controlled trial comparing the analgesic efficacy, onset, duration, side effects, and patient satisfaction between IV opioids and ultrasound-guided hematoma block in patients presenting to the ED with clavicle fractures. We hypothesize that UGHB will provide comparable or superior pain relief with fewer side effects and higher patient satisfaction, supporting its broader integration into emergency analgesia protocols. |