| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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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 |
|
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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
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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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