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CTRI Number  CTRI/2022/04/041990 [Registered on: 20/04/2022] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare effect of two nerve blocks PENG block around shoulder and Superior brachial trunk block in decreasing pain after arthroscopic shoulder surgeries.  
Scientific Title of Study   Comparison of Superior Brachial Trunk Block and Peri-capsular Nerve Group Block of Shoulder Joint in Arthroscopic Shoulder surgery: A Randomized Non-Inferiority Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dadi Uma Gowri Sankar 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 5011, Teaching block, Department of Anaesthesiology, pain medicine and critical care, All India Institute of Medical sciences, Ansari Nagar, new Delhi

South
DELHI
110029
India 
Phone  9581665158  
Fax    
Email  dadiumagowrisankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bikash Ranjan Ray 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 5011, Teaching block, Department of Anaesthesiology, pain medicine and critical care, All India Institute of Medical sciences, Ansari Nagar, new Delhi

South
DELHI
110029
India 
Phone  9899323110  
Fax    
Email  bikashray.aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bikash Ranjan Ray 
Designation  Associate professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room number 5011, Teaching block, Department of Anaesthesiology, pain medicine and critical care, All India Institute of Medical sciences, Ansari Nagar, new Delhi

South
DELHI
110029
India 
Phone  9899323110  
Fax    
Email  bikashray.aiims@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, pain medicine and Critical care, All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Room number 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 
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 
Dadi Uma Gowri Sankar  All India Institute of Medical Sciences  Room number 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
South
DELHI 
9581665158

dadiumagowrisankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for post graduate research, AIIMS  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, (2) ICD-10 Condition: 4||Measurement and Monitoring, (3) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pericapsular Nerve Group (PENG) block around shoulder joint  15 ml of 0.5% ropivacaine will be injected between subscapularis tendon below and deltoid muscle above under ultrasound guidance followed by post operative follow up with pca pump for 24 hrs 
Comparator Agent  Superior brachial trunk block  15ml of 0.5% ropivacaine will be injected around superior trunk of brachial plexus under ultrasound guidance followed by post operative follow up with pca pump for 24 hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) ASA I to III patients.
2) Age group of 18-80
3) Scheduled for elective unilateral arthroscopic
surgery. 
 
ExclusionCriteria 
Details  1. Patients who refused to participate in the study.
2. Patients with a history of cardiac, renal, or hepatic disease
3. Patients with Pre-existing neurologic deficits or neuropathy affecting the brachial plexus
4. Patients with Contraindications to peripheral nerve block
5. Patients with known allergy to local anaesthetics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Cumulative opioid
consumption at 24hrs, after arthroscopic shoulder surgery
between superior brachial trunk block and PENG block around shoulder with a prespecified non inferiority level of 15%.  
24hrs after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare between the two groups the following parameters:
1) 24hr pain intensity on an 11-point numerical rating score
2) Time for first analgesic requirement
3) Motor blockade
4) Patient satisfaction with pain relief at 24hrs
5) Surgeon Satisfaction
6) Diaphragmatic Excursion
7) complications 
During intra operative period and 24hrs postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="59" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/04/2022 
Date of Study Completion (India) 23/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Early postoperative pain immediately following shoulder surgery is a major concern and cause of distress for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of the patient’s recovery, hence regional anaesthesia plays an important role in decreasing the pain following shoulder surgeries. Superior Brachial trunk block a variant of conventional interscalene block is found to be non inferior to latter in providing adequate post operative analgesia. However superior brachial trunk block like interscalene block is associated with incidence of hemi diaphragmatic paresis due to local anaesthetic spread around the phrenic nerve. PENG block around shoulder joint is a new motor sparing block that causes only sensory blockade that needs to be evaluated. 
Standard Pre-Anesthetic Check Up will be done preoperatively and no premedication will be given. Informed and written consent will be taken from the patients while educating them about PCA machine and 11-points numerical rating scale for pain. When the patient arrives pre-op holding area: Baseline ipsilateral dome Diaphragmatic Ultrasound (T1) will be done for diaphragmatic excursion. Patient is randomly allocated via a sealed envelope to get either a superior brachial trunk block or PENG block around shoulder. In the operating room: standard monitoring will be done (HR, RR, NIBP, SpO2, EtCo2). Depending on the group to which the patient will be allocate either superior brachial trunk block or PENG block around shoulder will be given. Under aseptic conditions high frequency linear transducer will be placed over the interscalene region and superior brachial trunk block will be carried out For patients allocated to PENG block round shoulder group, high frequency linear transducer will be placed longitudinally between coracoid process and head of humerus and drug will be injected between subscapularis tendon below and deltoid muscle above. Drug to be used: 0.5% ropivacaine 15ml in both the blocks. Drug injected time will be taken as T0. At T20 motor blockade will be assessed. Patient will be induced with fentanyl 2mcg/kg, propofol 1.5 – 2 mg/kg, atracurium 0.5mg/kg followed by tracheal intubation. Maintenance: sevoflurane with air and oxygen. Intra operatively bolus of fentanyl 0.5mcg/kg will be given if heart rate and blood pressure increase by > 20% of baseline. Complications if any will be managed as per standard protocol. At the end of surgery reversal will be done with neostigmine and glycopyrrolate followed by extubation, and the patient will be shifted to PACU. Post operatively: USG will be done to find out diaphragmatic excursion. PCA pump will be attached to the patient that delivers 25mcg of fentanyl on demand with a lockout interval of 15 mins, with no basal dose. Inj PCM 10-15 mg/kg 6 hourly will be supplemented and injection ketorolac 0.5mg/kg iv 12 hourly as a part of multimodal analgesia, and if patient complains of pain more than 4/10 on VAS then 75-100 mcg/kg of morphine will be given. After 24 hrs. PCA pump will be disconnected and total fentanyl consumed will be noted. In addition, rescue opioids given if any are also noted, pain according to VAS from 0 – 10 is noted, patient satisfaction, surgeon satisfaction and complications if any will be noted down. The collected data will be analyzed using SPSS 20.1 (IBM Corp). Parametric variables will be described as mean ± standard deviation and qualitative variables were described as number (percentage) and as median and range.
 
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