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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anmol15@rediffmail.com].

  6. 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.

  7. 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.

 
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