FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039525 [Registered on: 18/01/2022] Trial Registered Prospectively
Last Modified On: 09/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare lateral sagittal and costoclavicular approaches for ultrasound guided infraclavicular brachial plexus block 
Scientific Title of Study   A prospective randomized interventional study comparing lateral sagittal and costoclavicular approaches for ultrasound guided infraclavicular brachial plexus block conducted at SMS medical college, Jaipur during 2021-2023 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhijith Rao 
Designation  Resident  
Affiliation  Sawai Man Singh medical college and hospital  
Address  Department of Anaesthesiology, 2nd floor, Dhanvantri building, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  8050304937  
Fax    
Email  arcontact006@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushil Kumar Bhati  
Designation  Senior Professor 
Affiliation  Sawai Man Singh medical college and hospital 
Address  Department of Anaesthesiology, 2nd floor, Dhanvantri building, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414779786  
Fax    
Email  drsushilbhati@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhijith Rao 
Designation  Resident  
Affiliation  Sawai Man Singh medical college and hospital  
Address  Department of Anaesthesiology, 2nd floor, Dhanvantri building, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  8050304937  
Fax    
Email  arcontact006@gmail.com  
 
Source of Monetary or Material Support  
Sawai Man Singh Medical college and hospital, Adarsh nagar, Jaipur 302004 
 
Primary Sponsor  
Name  Dr Abhijith Rao 
Address  Department of anaesthesiology, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur 302004 
Type of Sponsor  Other [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 Abhijith Rao  Sawai man Singh medical college and hospital  Department of Anaesthesiology, 2nd floor, Dhanvantri building, Adarsh nagar, Jaipur-302004
Jaipur
RAJASTHAN 		 8050304937

arcontact006@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S.M.S. Medical college and attached hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S499||Unspecified injury of shoulder andupper arm, (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, (3) ICD-10 Condition: S699||Unspecified injury of wrist, handand finger(s),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Infraclavicular brachial plexus block by costoclavicular approach  A transverse scan is performed immediately below the midpoint of the clavicle and over the medial infraclavicular fossa. The transducer is tilted slightly cephalad to direct the ultrasound beam towards the costoclavicular space. The ultrasound image is optimized until all 3 cords of the brachial plexus are visualized lateral to the axillary artery. The block needle is inserted in the plane from a lateral to medial direction. The aim is to place the needle tip at the center of the cord cluster by advancing it through the gap between the lateral and posterior cords. 25 mL of 0.5percent ropivacaine is slowly injected at a single site, without any needle redirection. 
Intervention  Infraclavicular brachial plexus block by lateral sagittal approach  A sagittal scan to be performed medial to the coracoid process to obtain a transverse view of the axillary artery. The ultrasound image is optimized to visualize all 3 cords of the brachial plexus. The skin cephalad to the ultrasound transducer will be infiltrated with 1 to 2 mL of lidocaine 1 percent, following which block needle will be inserted using in the plane technique and advanced towards the posterior aspect of the axillary artery. After negative aspiration for blood, 12.5ml of 0.5percent ropivacaine will be injected in small aliquots. The block needle is then gradually withdrawn until its tip is located cranial to the artery after which another 12.5ml of 0.5percent ropivacaine will be injected. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with injuries on upper limb requiring surgery  
 
ExclusionCriteria 
Details  1.Uncooperative patients.
2.Coagulopathies, any pre existing neurological disorders.
3.Allergy to Ropivacaine
4.Local pathology at the injection site
5.Any disability limiting the performance of block 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time for onset of sensory and motor block  3 minutes to 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Time of readiness of surgery   3 minutes to 30 minutes 
Time of first rescue analgesia  3 hours to 12 hours 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 07/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arcontact006@gmail.com].

  6. For how long will this data be available start date provided 28-01-2023 and end date provided 28-01-2056?
    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 is a randomized, single blind, parallel group, single center trial comparing lateral sagittal and costoclavicular approaches of infraclavicular brachial plexus block in 128 patients who will undergo upper limb surgeries. The primary outcome measures will be time of onset of sensory and motor block. The secondary outcome measures will be time to readiness for surgery and time of first rescue analgesia. 
Close