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CTRI Number  CTRI/2024/05/067970 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the pain relief and occurrence of diaphragm (muscle of respiration) paralysis with two different techniques of blocking the nerves supplying sensation to the shoulder joint during shoulder surgeries. 
Scientific Title of Study   Comparison of combined suprascapular and axillary nerve block versus superior (upper) trunk block for phrenic nerve sparing analgesia in patients undergoing arthroscopic shoulder surgery A randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AIIMS/IEC/2024/5062 dated 08/04/24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadik Mohammed 
Designation  Additional Professor 
Affiliation  Department of Anaesthesiology and Critical Care, AIIMS, JODHPUR 
Address  Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sadik Mohammed 
Designation  Additional Professor 
Affiliation  Department of Anaesthesiology and Critical Care, AIIMS, JODHPUR 
Address  Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Disha 
Designation  Junior Resident 
Affiliation  Department of Anaesthesiology and Critical Care, AIIMS JODHPUR. 
Address  Department of Anaesthesiology and Critical Care, All India institute of medical sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  8708975749  
Fax    
Email  VANLIKA16U@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur. Rajasthan (INDIA) 342005  
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan (INDIA) 342005 
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 Sadik Mohammed  AIIMS JODHPUR  Department of Anaesthesiology and Critical Care, 3rd Floor, DnT Block, AIIMS, Phase II, Basni Industrial Area, Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 
9414849733

drmsadik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  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  GROUP SSN & AN (combined SSN and AN block)  All patients will receive US-guided SSN and AN block with 20 mL 0.5% ropivacaine.  
Comparator Agent  Group ST Superior Trunk Block  All patients will receive ultrasound (US) guided ST block with 15 mL 0.5% ropivacaine.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult patients aged 18-60 years
2. Belonging to with ASA I/II/III category
3. Belonging to either sex,
4. Scheduled for unilateral shoulder orthopaedic surgery and providing consent for the procedure. 
 
ExclusionCriteria 
Details  1. Pregnant female,
2. Patient with baseline cognitive deficits sufficient to make objective pain assessment unreliable,
3. Patients with coagulopathy, liver and renal dysfunction,
4. Preoperative neurological deficits and allergy to amide local anaesthetics.
5. BMI exceeding 30 kg/m2, mental disorders, chronic obstructive pulmonary disease or any respiratory ailment, coagulation disorders, prior trauma, neuropathy, myopathy, and the need for open surgery.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The composite primary outcome of the study will be the comparison of phrenic nerve sparing analgesia. Phrenic nerve sparing will be assessed as diaphragmatic excursion using ultrasound while the pain will be assessed both at rest and during movement using a numeric rating scale (NRS)   From preoperative (Baseline) to first 24 hours postoperative. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of time to first rescue analgesia and total analgesic consumption.  During the first 24 hours. 
Comparison of pulmonary function (FVC, FEV1 & FEV1/FVC ratio) using portable spirometer.  At baseline and at 30 mins after the procedure 
Comparison of procedure-related complications if any in both groups.  During first 24 hours in the postoperative period. 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   03/06/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Patients undergoing shoulder arthroscopic surgeries experience intense pain in the postoperative period that interferes with recovery and rehabilitation. Peripheral nerve blocks (PNBs) are the preferred choice to provide adequate intraoperative and postoperative analgesia. Among PNBs, the interscalene approach of the brachial plexus block (ISB) is considered to be the standard and the most commonly used block for shoulder surgeries. It provides good perioperative analgesia but is inevitably known to cause hemidiaphragmatic paralysis due to ipsilateral phrenic nerve blockade which can lead to respiratory distress, especially in patients with cardio-pulmonary compromise. The superior trunk (ST) block has been described as a refinement of the conventional ISB technique where LA is injected around the ST which is formed by fusion of C5 and C6 nerve roots. ST block produces non-inferior analgesia of the shoulder compared to ISB as all the nerves innervating the shoulder arise distal to the ST. Also, the site of injection is further away from the phrenic nerve theoretically reducing the risk of hemidiaphragmatic paresis. The major nerve supply of the shoulder joint arises from the suprascapular nerve (SSN) and axillary nerve (AN). Combined blockade of these two nerves has been shown to provide equivalent analgesia to ISB in shoulder surgeries with complete elimination of the risk of hemidiaphragmatic paresis.

These two blocks i.e. ST block and combined SSN &AN block have not been compared for their phrenic nerve sparing analgesia. Therefore, we plan a study to compare these two block in terms of phrenic nerve sparing analgesia.

The enrolled patients will be randomly divided into two groups by using a computer-generated random number table and the allocation concealment will be done by a sealed opaque envelope method that will be opened just before starting premedication.

Group ‘ST’ (Superior Trunk Block)- All patients will receive ultrasound (US) guided ST block with 15 mL 0.5 percent ropivacaine.

Group ‘SSN & AN’ (combined SSN and AN block)- All patients will receive US-guided SSN and AN block with 20 mL 0.5 percent ropivacaine.

The outcome assessor/sonographer (assessing diaphragmatic excursion and NRS score) will be blinded to the group allocation.

On the day of surgery, in the preoperative area, a blinded observer will perform a US examination to determine baseline diaphragmatic excursion. The baseline pulmonary function, including forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the FEV1/FVC ratio will be assessed and recorded using a portable spirometer.

30 minutes after placement of the block, a repeat assessment of diaphragmatic excursion and IC will be performed and recorded. 

 
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