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CTRI Number  CTRI/2024/11/076323 [Registered on: 06/11/2024] Trial Registered Prospectively
Last Modified On: 10/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare incidence of hemidiaphragmatic parasis in two regional blocks in surgeries of upper limb. 
Scientific Title of Study   Comparison of Hemidiaphragmatic Paresis after ultrasoundguided Costoclavicular versus Supraclavicular brachial plexus block in elective upper limb surgeries - A Randomised 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  Ajinkya Kalbande 
Designation  Junior Resident 
Affiliation  NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9923054112  
Fax    
Email  ajinkyak31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Heena Pahuja 
Designation  Professor, Department of Anaesthesiology 
Affiliation  NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9823188160  
Fax    
Email  heenapahuja15@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ajinkya Kalbande 
Designation  Junior Resident 
Affiliation  NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9923054112  
Fax    
Email  ajinkyak31@gmail.com  
 
Source of Monetary or Material Support  
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Hingna , Nagpur - 440019 
 
Primary Sponsor  
Name  NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital 
Address  Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur 
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 Ajinkya Kalbande  NKPSIMS  NKP Salve Institute of Medical sciences and Research centre and Lata Mangeshkar Hospital, Digdoh hills, Hingna, Nagpur, Anaesthesia department
Nagpur
MAHARASHTRA 
9923054112

ajinkyak31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nkp salve institute of medical sciences and Research centre and Lata Mangeshkar Hospital institutional ethical committee Digdoh hills, Hingna , Nagpur 440019  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  Ultrasound Guided Costo-Clavicular Block  Injection Ropivacaine 0.5% 20ml 10 minutes prior to surgery 
Comparator Agent  Ultrasound Guided Supraclavicular Block  Injection Ropivacaine 0.5% 20ml 10 minutes prior to surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient scheduled for elective upper limb surgery
2. ASA class 1,2,3
3. BMI less than 30 kg/m2 
 
ExclusionCriteria 
Details  1.Patients unable to cooperate or consent to surgery
2.Preexisting neuropathy
3.Significant pulmonary disease
4.Contralateral phrenic nerve palsy or diaphragmatic dysfunction
5.Allergy to local anaesthetics
6.Infection at needle insertion site 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to
• Diaphragmatic excursion measurement using M-mode during
-Normal breathing,
- Deep breathing and
-Voluntary sniff manoeuvre. 
To compare the incidence of hemidiaphragmatic paresis between ultrasound guided Supraclavicular brachial plexus block and ultrasound guided Costoclavicular brachial plexus block in elective upper limb surgeries with respect to
• Diaphragmatic excursion measurement using M-mode during
-Normal breathing,
- Deep breathing and
-Voluntary sniff manoeuvre
At intervals of 15 minutes and 30 minutes post block 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the block characteristics between ultrasound guided supraclavicular brachial plexus block and ultrasound guided costoclavicular brachial plexus block for elective upper limb surgeries with respect to
1 Block performance time
2 Sensory onset time
3 Motor onset time
4 Total block score 
Patient will be monitored for the above parameters from the time of giving block till 30 mins 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) 30/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

•      Ultrasound-guided supraclavicular (SC) and infraclavicular (IC) approaches have become increasingly common brachial plexus blocks (BPBs) for upper-extremity surgery, because of the greater safety of these methods due to real-time ultrasound guidance and faster onset times.

•      The occurrence of hemidiaphragmatic paresis depends on site of injection with the incidence being 45-100% for interscalene brachial plexus block, 28-67% for supraclavicular brachial plexus block and 13-24% for lateral sagittal infraclavicular brachial plexus block.

•      Hemidiaphragmatic paresis (HDP) is a frequent complication of the brachial plexus block, caused by unintentional blockade of the phrenic nerve, especially when the block is performed above the clavicle.

•      The costoclavicular brachial plexus block (CCB) is a recently introduced infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space

•      The CCB can provide a successful and rapid onset of the blockade with a single injection of a relatively small volume of local anaesthetic.

•      The costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anesthesia, same as supraclavicular block and also there are chances of hemidiaphragmatic paresis. However the incidence of hemidiaphragmatic paresis after costoclavicular block is not clearly known.

•       HDP can be easily tolerated in normal patients but it can cause complications in COPD patients. Hence our study to find out incidence of hemidiaphragmatic paresis after CCB will be useful.

•      As there are very few studies comparing the hemidiaphragmatic paresis after ultrasound- guided supraclavicular and costoclavicular brachial plexus block in elective upper limb surgeries, we would like to conduct this study comparing the two blocks.


 
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