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CTRI Number  CTRI/2024/05/067845 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Ultrasound guided infraclavicular brachial plexus block with 2 different approaches 
Scientific Title of Study   An observational study of ultrasound guided infraclavicular brachial plexus block with Costoclavicular and Retroclavicular approaches for upperlimb orthopedic surgeries  
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 Dhrumi Sutariya  
Designation  2nd year Anesthesia resident  
Affiliation  New civil hospital surat 
Address  2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat GUJARAT 395001 India

Surat
GUJARAT
395001
India 
Phone  9726809725  
Fax    
Email  ddsutariya9725@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bansari N Kantharia  
Designation  Additional professor  
Affiliation  New surat civil hospital Surat 
Address  2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat GUJARAT

Surat
GUJARAT
395001
India 
Phone  9825690177  
Fax    
Email  bansarikantharia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bansari N Kantharia 
Designation  Additional professor  
Affiliation  New surat civil hospital Surat 
Address  2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat GUJARAT

Surat
GUJARAT
395001
India 
Phone  9825690177  
Fax    
Email  bansarikantharia@gmail.com  
 
Source of Monetary or Material Support  
Government medical college and new civil hospital surat, Gujarat, India Pincode- 395001 
 
Primary Sponsor  
Name  Government medical college and new civil hospital Surat 
Address  New civil Hospital, near Majura gate, Surat, pincode- 395001 , Gujarat, India 
Type of Sponsor  Government medical college 
 
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 Dhrumi Sutariya   Government medical College and new civil hospital surat  First floor Orthopaedic operation theatre in OT building
Surat
GUJARAT 
9726809725

ddsutariya9725@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee, Government Medical College, Majuragate , surat  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infraclavicular brachial plexus block   Patients posted for upper limb orthopaedic surgery and fulfilling my inclusion criteria Usg guided Infraclavicular brachial plexus block will be given by retroclavicular approach or Costcoclavicular approach as a mode of Anaestheasia . Infraclavicular brachial plexus block will be given using insulated block needle using a combination of; -Inj. Bupivacaine(0.5%) 20 ml ,Inj. Lignocaine (2%) 10 ml, Inj. Dexamethasone 2 ml. Total 32 ml volume will be given.I will observe the block performance time ,quality of block, will observe the Duration of motor and sensory block for 24 hours . Will note the analgesic requirements for 24 hours after block is given. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients who will undergo planned upper limb surgeries under usg guided Infraclavicular brachial plexus block with Costoclavicular and Retroclavicular approaches and giving written informed consent.
2. Patients belonging to ASA class 1, 2,3 .
3.Patients of either sex, in the age group of 18 to 65yrs. 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to local anaesthetics.
2. Infection at the site of block . 3. Morbidly obese patient.
4.Patients with neurological, psychiatric or neurovascular disorders.
5.Patients with major cardio-pulmonary or hepato renal compromise.
6. Pregnant patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Block performance time.
2) Block characteristics- onset and duration of sensory and motor block
3)Quality of block. 
1) Block performance time will be assessed from time of needle insertion to time of injecting drug
2) Block characteristics- onset and duration of sensory and motor block for 24 hours
3)Quality of block. 
 
Secondary Outcome  
Outcome  TimePoints 
1)Duration of post operative analgesia and requirement of analgesics in 24 hours.
2)Intraoperative Hemodynamic changes.
3)Complications/Adverse events if any 
Till 24 hours after giving block 
 
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   Phase 3 
Date of First Enrollment (India)   02/06/2024 
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="1"
Months="3"
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  
Most upper limb surgeries are done under brachial plexus block as it provides anesthesia along with postoperative analgesia without any need of airway manipulation.
According to site of injury and other factors Brachial plexus block is given through various approaches like Interscalene block, Supraclavicular, Infraclavicular or Axillary .Infraclavicular block provides excellent anesthesia for upper limb surgeries.
The infraclavicular brachial plexus has easily recognisable sonoanatomy, a high success rate, and low risk of pnemothorax. Identification of the axillary artery is the key landmark in performing this block.The use of ultrasound (USG) adds valuable information such as visualisation of the needle tip and real-time observation of the injectate surrounding the nerves. Use of USG also reduces the risk of adverse events such as inadvertent intravascular injection and trauma to surrounding structures.
In the costoclavicular approach, the ultrasound transducer is placed parallel to and below the clavicle. In this view, the cords are clustered together, at a more superficial level,the cords could be blocked more rapidly with the CC approach and that the block is administered faster and requires a fewer number of needle redirections. There is no increased incidence of pneumothorax with the CC approach.
The Retroclavicular approach consists of inserting the needle in the supraclavicular fossa, behind the clavicle, in-plane in a paramedian sagittal plane cephalo-caudad direction until the needle tip is positioned behind the axillary artery with the US probe resting in the delto-pectoral groove.The point of needle insertion, however, is over the trapezius muscle posteriorly. This approach allows the needle to pass between the scapula and the clavicle toward the axillary artery in the infraclavicular area.
These two techniques are simple, reliable ,safe and effective.In our institute so far no study evaluating the characteristics of these two techniques is done. Hence, we are planning to do this study.


 
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