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CTRI Number  CTRI/2025/08/093884 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two types of nerve blocks namely superior trunk block and interscalene block to see which one causes less breathing muscle weakness in patients undergoing arm(humerus) surgery 
Scientific Title of Study   Comparison of the incidence of Hemidiaphragmatic paresis following ultrasound-guided superior trunk block and interscalene block for elective humerus surgeries- a randomised controlled 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 Srushti Bari 
Designation  Junior Resident 
Affiliation  Bharati Vidyapeeth Deemed to be University and Medical College 
Address  Department of Anesthesia Bharati Vidyapeeth Deemed to be University medical college Pune Satara Road Dhanakwadi Pune Maharashtra

Pune
MAHARASHTRA
411043
India 
Phone  9833749608  
Fax    
Email  srushtibari28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalyani Patil 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University 
Address  Department of Anesthesia Bharati Vidyapeeth Deemed to be University Dhanakwadi Pune Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9673400066  
Fax    
Email  kalyanish19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srushti Bari 
Designation  Junior Resident 
Affiliation  Bharati Vidyapeeth Deemed to be University 
Address  Department of Anesthesia Bharati Vidyapeeth Deemed to be University Dhanakwadi Pune Pune

Pune
MAHARASHTRA
411043
India 
Phone  9833749608  
Fax    
Email  srushtibari28@gmail.com  
 
Source of Monetary or Material Support  
Bharati Hospital and Research Centre 
 
Primary Sponsor  
Name  BHARATI HOSPITAL AND RESEARCH CENTRE 
Address  Bharati hospital and Research centre, Dhankwadi, Pune, 411043 
Type of Sponsor  Research institution and hospital 
 
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 Kalyani Patil  Bharati Hospital Pune   Department of Anesthesia ,3rd floor ,Major OT Complex Bharati Hospital Dhanakwadi Pune 411043 Maharashtra
Pune
MAHARASHTRA 
9673400066

kalyanish19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S423||Fracture of shaft of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable   Not Applicable  
Comparator Agent  Ultrasound guided Interscalene Block using 0.75% ROPIVACAINE 15ml   Patients undergoing elective humerus surgeries will be divided into two groups of 28 each by using a computer-generated method namely Group S will receive ultrasound-guided Superior Trunk block using ROPIVACAINE 0.75 percent 15ml and Group I will receive ultrasound-guided Interscalene block using ROPIVACAINE 0.75 percent 15ml and Diaphragm will be studied using ultrasound to look for paresis  
Comparator Agent  Ultrasound guided Superior Trunk Block using 0.75% ROPIVACAINE 10ml  Patients undergoing elective humerus surgeries will be divided into two groups of 28 each by using a computer-generated method Group S: will receive ultrasound-guided Superior Trunk block using ROPIVACAINE 0.75% 15ml and Group I: will receive ultrasound-guided Interscalene block using ROPIVACAINE 0.75% 15ml and diaphragm will be studied using ultrasound to look for paresis  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiologists (ASA) Grade I & II patients, of both sexes.
2.Patients undergoing elective upper limb surgeries.
3.Patients in the age group of 18-60 years.
 
 
ExclusionCriteria 
Details  1. Known allergy to local anaesthetic
2. Patients with respiratory system compromised
Patients with psychiatric disorders/seizure disorders
3.Patient refusal to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare incidence of hemidiaphragmatic paresis following superior trunk and interscalene block in patients undergoing humerus surgeries.  Post operative 30 mins  
 
Secondary Outcome  
Outcome  TimePoints 

1.To assess the time required to achieve sensory blockade and motor blockade following superior trunk block and interscalene block in patients undergoing humerus surgeries.
2.To assess the duration of analgesia following superior trunk block and interscalene block in patients undergoing humerus surgeries.
3.To access respiratory function- Peak Expiratory Flow Rate (PEFR) using spirometer pre block and post block. 
Post operative 24 hours  
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 1/ Phase 2 
Date of First Enrollment (India)   08/09/2025 
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="2"
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  

After obtaining approval from the institutional ethical committee and informed consent from all patients in a language understood by them, a total of 56 patients (28 in each group) of ASA I & II undergoing elective humerus surgery will be included in the study.Patients will be divided into two groups of 28 each by using a computer-generated method (Research Randomizer), namely Group S, Group I. Group S-will receive ultrasound-guidedSuperior Trunk block using ROPIVACAINE 0.75% 15ml.Group I: will receive ultrasound-guidedInterscalene block using ROPIVACAINE 0.75% 15ml.

Spirometry will be done in sitting position before giving the block and 15 mins after giving the block and after shifting patient to PACU to assess the PEFR.Diaphragm will be assessed pre-operatively using USG machine so as the know the original condition of diaphragm. All blocks will be placed under sterile conditions in the operating room with sedation (intravenous midazolam 1-2 mg) The Interscalene block will be performed using a linear ultrasound transducer and PNS.After identifying the cervical roots and interscalene muscles, a 22-gauge needle will be inserted, lateral to medial, with in-plane technique into the interscalene groove. The tip of the needle will be placed in between C5 and C6, and 15 ml of 0.75% Ropivcaine will bedeposited. For the superior trunk block, after identifying the cervical roots and scalene muscles, the probe will be moved distally until the suprascapular nerve branches off the superior trunk are seen. The targeted level of insertion for the injection will be immediately before the branching off point of the suprascapular nerve. A 22G needle will be inserted, lateral to medial, using in-plane technique. The tip of the needle will be placed posterior/inferior to the trunk, and 10 ml0.75% Ropivacaine will be injected. 5ml will be injected anteriorly. After 15 to 20 min of the nerve block, each patient will have a sensory and motor examination by the anaesthesiologist to ensure blockade of the C5 and C6 nerve roots. Each patient will be assessed for numbness in the hand/arm and weakness during shoulder abduction. 

In the event of an inadequate or failed blockade, general anaesthesia or supplemental blockade will be done before surgical incision and the patient will be excluded from further analysis. Sensory and motor blockades were assessed every 5 mins for 30 mins. The onset time for a sensory block was defined as the time elapsed between the end of the block procedure and the moment when the pinprick test yielded a score of 2. Failure to reach a score of 2 within 30 min of interscalene block was considered to be block failure, and the patient will be excluded from the study. Diaphragmatic excursion will be assessed

1. 15 mins before the block 

2. 15 mins after the time of completion of block

3. 30 mins after the shifting the patient to PACU

Duration of Analgesia and use of rescue analgesic will be assessed 8 hourly for next 24 hours using NRPS scale 


 
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