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CTRI Number  CTRI/2025/12/098651 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 06/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of two approaches of brachial plexus block- costoclavicular and supraclavicular brachial plexus block- in patients undergoing upperlimb surgeries 
Scientific Title of Study   A comparative study of ultrasound guided costoclavicular versus supraclavicular brachial plexus block in patients undergoing upperlimb surgery. 
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 Geetha CR 
Designation  Professor 
Affiliation  MS Ramaiah Medical College and Hospital 
Address  Department of Anaesthesiology, Second floor, MS Ramaiah Medical College, New BEL Road, Bangalore - 560054 Bangalore, KARNATAKA

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetha CR 
Designation  Professor 
Affiliation  MS Ramaiah Medical College and Hospital 
Address  Department of Anaesthesiology, Second floor, MS Ramaiah Medical College, New BEL Road, Bangalore - 560054 Bangalore, KARNATAKA

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetha CR 
Designation  Professor 
Affiliation  MS Ramaiah Medical College and Hospital 
Address  Department of Anaesthesiology, Second floor, MS Ramaiah Medical College, New BEL Road, Bangalore - 560054 Bangalore, KARNATAKA

Bangalore
KARNATAKA
560054
India 
Phone  9900482828  
Fax    
Email  jageedha@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah medical college ,New BEL Road, MSRIT Post, Bangalore – 560054 
 
Primary Sponsor  
Name  MS Ramaiah medical college 
Address  New BEL Road, MSRIT Post, Bangalore – 560054 
Type of Sponsor  Private 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 Prakruthi RV  MS Ramaiah Medical College  Department of Anaesthesiology,Second floor, MS Ramaiah Medical College,New BEL Road, Bangalore - 560054Bangalore, KARNATAKA
Bangalore
KARNATAKA 
6360070245

Prakruthirv08@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MS Ramaiah medical college Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  To compare the efficacy of supraclavicular and costoclavicular brachial plexus block in patients undergoing upper limb surgeries   To compare the costoclavicular and supraclavicular approach of brachial plexus with respect to onset of sensory and motor blockade.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients aged between 18 to 65 years posted for elective upperlimb surgeries.
2) American Society of Anaesthesiologists (ASA) physical status 1and 2
 
 
ExclusionCriteria 
Details  1) Pre-existing pulmonary pathologies.
2) Pre-existing known neuropathy concerning the forearm present surgery.
3) Infection on the needle insertion site.
4) Coagulopathies.
5) Pregnancy.
6) Body mass index more than 30kg/m2.
7) Allergy to local anaesthetics.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the onset of complete sensory and motor blockade at after LA injection.  . The sensory blockade of the four nerves will be evaluated and graded every 3 mins until 30 mins after injection by double blinded observers using a 3 point scale (0 = no block , 1 = analgesia i.e patient can feel touch but not cold, 2 = anaesthesia i.e patient cannot feel touch). Motor blockade will be tested and graded according to a 3 point scale ( 0 = no block, 1 = paresis, 2 = paralysis). Motor blockade of each nerve will be evaluated by elbow flexion for (MCN), wrist flexion for (MN), wrist extension for (RN), flexion and opposition of fifth finger towards the thumb for (UN).
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the performance time, number of needle passess and duration of analgesia between the two techniques.
To assess the incidence of complications such as hemidiaphragmatic dysfunction, pneumothorax, Horners syndrome and vessel puncture.
To assess the incidence of block failure or rescue analgesia.
 
VAS score will be assessed to elicit the duration of post operative analgesia at predetermined time intervals 0th (at the onset of sensory blockade), 2, 4, 6, 12, 18, 24th hour. To assess the incidence of diaphragmatic dysfunction,anaesthesiologist will perform repeat ultrasound within 1 hour of the patient’s arrival in the recovery room after the surgery. 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   01/01/2026 
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="2"
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 - 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 - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [Prakruthirv08@gamil.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

 One of the most popular methods of administering anaesthesia and pain releif for upper limb surgery is a regional brachial plexus block. Brachial plexus can be blocked by supraclavicular, infraclavicular, costoclavicular, axillary and  interscalene approaches.

The use of ultrasound in these blocks enhances the success rates and reduces complications significantly. It improves the visualisation of nerve bundles, enables real time assessment of needle placement and this has lead to reduction in the total volume of anaesthetic drugs required. It also helps in avoiding crucial structures such as pleura, blood vessels and  enhances the precision of the local anaesthesic drug infiltration along the targeted nerves.

Supraclavicular brachial plexus block(SCBPB) is often called the  spinal  anaesthesia of the arm, due to its rapid onset of blockade. For the supraclavicular (SC) approach, the trunk and divisions of the brachial plexus are arranged compactly superolaterally around the subclavian artery at the supraclavicular fossa. However, complications such as hemidiaphragmatic paralysis due to phrenic nerve blockade, Horner’s syndrome due to sympathetic nerve block and pneumothorax may occur.

Costoclavicular approach of BPB is a modification of ultrasound guided infraclavicular approach of BPB. Under ultrasound guidance, the costoclavicular space (CCS) is visualised as a well defined intermuscular space , lying deep and posterior to midpoint of clavicle. It is located between the clavicular head of pectoralis major and subclavius muscle anteriorly and the upper slips of serrtus anterior muscle and second rib posteriorly.  All 3 cords of brachial plexus are more superficial and visualized in a single transverse sonogram of CCS as the cords are clustered together lateral to axillary artery. Therefore a a low dose of LA(local anaesthetic) and single injection would provide more effective blockade. Block needle can be easily directed to the centre of the plexus with minimal discomfort to patient.

The danger of vascular puncture and pleural puncture is minimized with costoclavicular approach as the nerve cords are first approached before vessel and the pleura.

 
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