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CTRI Number  CTRI/2025/02/080388 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 02/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To evaluate hemidiaphragmatic Paralysis after costoclavicular brachial plexus block through ultrasound  
Scientific Title of Study   Ultrasonographric evaluation of Hemidiaphragmatic paralysis following costoclavicular approch to brachial plexus block : A prospective observational study  
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 Naval Jethaliya  
Designation  Junior Resident doctor in MD Anesthesiology  
Affiliation  Department of Anaesthesia  
Address  Department of Anesthesia Lokmanya Tilak Municipal Medical College & sion Hospital ,sion ,mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  07588421514  
Fax    
Email  navaljethaliya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devangi Parikh  
Designation  Associate Professor , Anesthesiology  
Affiliation  Lokmanya Tilak Municipal Medical College & sion Hospital , sion , mumbai  
Address  Department of Anesthesia

Mumbai
MAHARASHTRA
400022
India 
Phone  9820471638  
Fax    
Email  sdevangi10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devangi Parikh  
Designation  Associate Professor , Anesthesiology  
Affiliation  Lokmanya Tilak Municipal Medical College & sion Hospital , sion , mumbai  
Address  Department of Anesthesia

Mumbai
MAHARASHTRA
400022
India 
Phone  9820471638  
Fax    
Email  sdevangi10@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal medical college & hospital , sion , Mumbai , Maharashtra 400022 
 
Primary Sponsor  
Name  Dr Naval Jethaliya 
Address  Department of anesthesia , Lokmanya Tilak Medical College , Sion hospital , Sion , Mumbai Maharashtra 400022 
Type of Sponsor  Other [] 
 
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 Naval Jethaliya  Lokmanya Tilak Municipal Medical College & sion Hospital  OT complex ,3rd floor, ward building Lokmanya Tilak Municipal Medical College & sion Hospital , sion , mumbai 400022
Mumbai
MAHARASHTRA 
7588421514

navaljethaliya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee human research  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: S59||Other and unspecified injuries ofelbow and forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Costoclavicular Brachial Plexus Block  usg guided Costoclavicular Brachial Plexus Block given for the surgeries of arm , forearms .And Diaphragmatic Paralysis observed in patients immediately after Block , 20 min after block & after completion of surgical procedure to detect the incident of diaphragm paralysis  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 years and above
2. American Society of Anesthesiology (ASA) physical status 1-3
3. Patient scheduled for upper limb (including elbow, forearm, hand and wrist)
surgeries under ultrasound guided CCB
4. Patients with no distal neurovascular deficit 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Infection at the puncture site/ distorted anatomy of the supraclavicular region /
burns
3. Allergic to local anesthetic drugs
4. Significant pulmonary disease in which respiratory compromise can be expected
in case of HDP
5. Coagulopathy, sepsis
6. Pregnant patients
7. Contra-lateral diaphragmatic paralysis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To calculate the incidence of Ipsilateral hemi-diaphragmatic paralysis using
ultrasonography after administration of us guided costoclavicular approach to Brachial
plexus block.
 
immediately after block , 20 min after block & post surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1) Effect of different volumes of local Anesthetic used for costoclavicular brachial
plexus block on hemi-diaphragmatic paralysis
2) Effect of different local anesthetics (Ropivacaine/ Bupivacaine/levobupivacaine)
used for block on diaphragmatic paralysis
3) Operator satisfaction using the two diaphragm assessment techniques 
immediately after block , 20 min after block & post surgery  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   01/03/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Upper limb surgeries are mainly performed under regional anesthesia as it is cost effective, easy to perform and provides better pain relief as compared to general anesthesia.[1] Brachial plexus provides nerve supply from shoulder to fingertips and it can be performed using various techniques. This includes interscalene block, superior trunk block, supraclavicular, infraclavicular, costoclavicular, lateral infraclavicular and axillary block by various approaches.
 [2] Hemi diaphragmatic paralysis (HDP) is a frequent complication of the brachial plexus block (BPB), caused by unintentional blockade of the phrenic nerve because of close proximity of brachial plexus and phrenic nerve that supplies diaphragm. Although HDP can reduce forced vital capacity and forced expiratory volume at 1 second but these reductions are generally well tolerated by most patients. HDP, however, can be a serious problem in some patients, including those with underlying lung disease or marginal pulmonary function. As brachial plexus and phrenic nerve move caudally they start to diverge from each other so a higher incidence of HDP is more likely to be associated with interscalene and supraclavicular block as compared to infraclavicular block.[4] The incidence of HDP after infraclavicular brachial plexus block is lower, likely due to the relatively long distance between the phrenic nerve and the block site.[3] Infraclavicular approach to BPB can be provided by traditional approach and the costoclavicular approach.[5] The costoclavicular brachial plexus block (CCB) is a relatively recently introduced (2018) infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space. Anatomically costoclavicular approach is better than traditional block through lateral infraclavicular P a g e | 24 HDP AFTER COSTOCLAVICULAR BPB DR NAVAL R JETHALIYA approach. In lateral infraclavicular fossa, the cords are located deep to pectoral muscles and separated from each other by the axillary artery[6]. This requires large volume of LA and multiple needle punctures for a successful block, whereas in the costoclavicular fossa cords are located superficially and clustered together[10] so small dose of LA and single needle puncture can provide adequate anesthesia.[9] Moreover, the infraclavicular brachial plexus block alone has limited utility in patients undergoing shoulder surgery because of the poor coverage of the proximal branch, such as the suprascapular nerve. Costoclavicular space is located deep and posterior to middle third of clavicle with subclavius and clavicular head of pectoral muscle anteriorly. Costoclavicular space continues as supraclavicular fossa cranially and medial infraclavicular fossa caudally. The costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anesthesia, including anesthesia to the suprascapular nerve during shoulder surgery. Because of these anatomical advantages, the CCB is emerging as a promising infraclavicular approach,[11] with several studies showing that the CCB can provide a successful and rapid onset of the blockade with a single injection of a relatively small volume of local anesthetic, with the effect similar to supraclavicular brachial plexus block. However, the costoclavicular space is located proximal to the lateral infraclavicular fossa, providing greater proximity to the phrenic nerve. The CCB may therefore increase the risk of HDP, with one study showing that local anesthetic injected into the costoclavicular space reached the interscalene region, at the level of the superior trunk.[12] Diaphragmatic dysfunction following brachial plexus blockade may be suspected based on clinical signs and symptoms of respiratory compromise. Traditional methods to confirm the diagnosis such as real-time fluoroscopy, pulmonary function testing, or even chest radiography involves radiation exposure, patient transportation, increased cost, are time consuming and can cause discomfort for the patient. Ultra-sonography (US) is an easy, reliable, real time, noninvasive and reproducible P a g e | 25 HDP AFTER COSTOCLAVICULAR BPB DR NAVAL R JETHALIYA alternative method to assess the diaphragm function that can be used at the bedside using standard ultrasound equipment which is readily available in the regional anesthesia block areas. Limited studies have primarily assessed the incidence of HDP following the CCB hence we planned a prospective observational cohort study to 
 
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