| CTRI Number |
CTRI/2025/02/080294 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided Suprascapular nerve block compared with intravenous fentanyl for analgesia in patients with traumatic scapular fractures: An open label prospective randomized controlled trial |
|
Scientific Title of Study
|
Ultrasound guided Suprascapular nerve block compared with intravenous fentanyl for analgesia in patients with traumatic scapular fractures: An open label prospective 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 Sanjeev Bhoi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine, Division: Emergency Medicine, Room number 12, Jai Prakash Narayan Apex Trauma Centre AIIMS New Delhi
South West DELHI 110029 India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjeev Bhoi |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine, Division: Emergency Medicine, Room number 12, Jai Prakash Narayan Apex Trauma Centre AIIMS New Delhi
DELHI 110029 India |
| Phone |
8527050391 |
| Fax |
|
| Email |
sanjeevbhoi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anmol Chanda |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Emergency Medicine, Division: Emergency Medicine, Jai Prakash Narayan Apex Trauma Centre AIIMS New Delhi
South West DELHI 110021 India |
| Phone |
09803313452 |
| Fax |
|
| Email |
anmol15@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Jai Prakash Narayan Apex Trauma Centre, AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Sanjeev Bhoi |
| Address |
Department of Emergency Medicine, Division: Emergency Medicine, Room number 12, Jai Prakash Narayan Apex Trauma Centre AIIMS New Delhi |
| Type of Sponsor |
Other [Dr Sanjeev Bhoi, Professor, (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 Sanjeev Bhoi |
Jai Prakash Narayan Apex Trauma Centre AIIMS New Delhi |
Department of Emergency Medicine, Division: Emergency Medicine, Red area of Emergency Department South West DELHI |
08527050391
sanjeevbhoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, (2) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Fentanyl |
Dose: 1mcg/Kg
Frequency: Stat dose
Route of administration: intravenous
Total duration of observation: 6 hours |
| Intervention |
Ultrasound Guided Suprascapular Nerve Block |
Dose and agent used:2-5 ml of Lignocaine 2% used
Frequency: stat dose
Route of administration: local infiltration
Total duration of observation: 6 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
adults
traumatic scapular fractures
high pain score greater than seven on DVPRS
giving valid consent |
|
| ExclusionCriteria |
| Details |
patients less than eighteen years old
not giving consent
in cardio respiratory arrest
coagulopathy
active hemorrhage
known allergy to local anesthetics
pregnant and lactating woman
unstable vital signs
altered mental status
patients who received anesthesia outside
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of analgesic efficacy and adverse events of Suprascapular nerve block compared to intravenous fentanyl |
Patients in both arms are followed up at baseline, 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.reduction in painful time
2.requirement of additional anesthesia
3.interrater agreement on performing nerve block procedure |
Patients in both arms are followed up at 30 min, 60 min, 120 min, 240 min and 360 min post intervention |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
20/02/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anmol15@rediffmail.com].
- For how long will this data be available start date provided 20-02-2025 and end date provided 20-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will be the first of its kind in one of the India’s high flow Emergency department. Scapular fractures are common and extremely painful which are frequently associated with dangerous injuries involving the thorax and craniospinal axis. These are usually caused by high energy dangerous mechanisms. Scapular fractures are usually treated conservatively with immobilization and physiotherapy and adequate analgesia. However, these painful scapular fractures prevent adequate movement of the shoulder girdle and hence physiotherapy cannot be performed adequately hence delaying the healing time associated with scapular fractures. Hence, clinical suspicion and prompt identification and adequate analgesia is required for treating these fractures. Analgesia with IV medications including NSAIDS, opioids have their own systemic side effects. The ultrasound guided suprascapular nerve block is an emerging modality for scapular fracture pain management in the ED that ensures precise drug delivery and minimizes complications. Although both ultrasound guided nerve block and IV analgesics have been reported to exhibit admirable analgesic efficacy for traumatic pain, their analgesic efficacy and patient satisfaction have not been compared in emergency settings. Optimal pain management is an essential quality of care indicator in Emergency settings There is a scarcity of medical literature (only case report) on the use of ultrasound guided suprascapular nerve block for scapular fractures. Hence the main aim of this study is to assess the analgesic efficacy of suprascapular nerve block, it’s complications and outcomes compared to IV analgesics for traumatic scapular fractures in a randomized controlled study. |