FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061067 [Registered on: 02/01/2024] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [CONTINUOUS SUPRASCAPULAR NERVE BLOCK]  
Study Design  Single Arm Study 
Public Title of Study   To study the effect of continuous supra scapular nerve block under ultrasound guidance in patients with chronic shoulder pain  
Scientific Title of Study   To study the efficacy of ultrasound guided continuous supra scapular nerve block in patients with chronic shoulder pain  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi J 
Designation  Junior Resident 
Affiliation  JSS Academy of Higher Education and Research 
Address  Department of Anaesthesiology, JSS Medical College and Hospital, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  8861789652  
Fax    
Email  sjagadish9166@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratibha Matche 
Designation  Associate Professor 
Affiliation  JSS Academy of Higher Education and Research 
Address  Incharge-Pain and Palliative Care Unit, Department of Anaesthesiology, JSS Medical College and Hospital, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9845055453  
Fax    
Email  pmatche@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratibha Matche 
Designation  Associate Professor 
Affiliation  JSS Academy of Higher Education and Research 
Address  Incharge-Pain and Palliative Care Unit, Department of Anaesthesiology, JSS Medical College and Hospital, Mysuru
Incharge-Pain and Palliative Care Unit, Department of Anaesthesiology, JSS Medical College and Hospital, Mysuru
Mysore
KARNATAKA
570004
India 
Phone  9845055453  
Fax    
Email  pmatche@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical College and Hospital, Mysuru. 
 
Primary Sponsor  
Name  JSS Academy Of Higher Education And Research 
Address  JSS Medical College and Hospital, Mysuru. 
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 SWATHI J   JSS Medical College and Hospital  Out patient department of Orthopaedics, Pain and palliative care unit in First floor, Operation Theatre complex and post operative ward in third floor, Orthopaedic wards in 4th floor at JSS Hospital, MG Road Agrahara 570004
Mysore
KARNATAKA 
8861789652

sjagadish9166@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS medical college, JSS Academy of Higher Education and Research, Institutional Ethical Committee  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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Ultrasound guided continuous suprascapular nerve block   Eligible patients will be assesed for intensity of pain by Numerical rating scale (NRS),shoulder pain and range of motion through Shoulder pain and disability index (SPADI),patient satisfaction by Global perceived index (GPI). Patients will be assesed at pre-procedure, immediate post procedure and at follow up intervals of 5 days ,2 ,4,12 and 24 weeks. In operative setting suprascapular catheter is placed using Ultrasound (USG-shortaxis-posterior approach). Bupivacaine 0.25% 7 ml and 1 ml Dexamethasone (4 mg) will be given. Immediate post procedure patient will be assesed and then shifted to ward with advise to start physiotheraphy Once in every 8 hours top up dose of 0.25% Bupivacaine 6ml given intermittently through catheter to facilitate physiotheraphy . catheter is removed after 5 days and patient is discharged with advice to follow home exercise programme . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of either sex between 18 to 80 years of age with chronic shoulder pain
Shoulder pain with duration of more than 3 months
Pain and Restriction of range of motion in one shoulder
Patients with shoulder pain NRS more than or equal to 4
patients not responding to conservative management


 
 
ExclusionCriteria 
Details  Patients with coagulopathy and or on anticoagulants
Infection at the site of injection
Hypersensitivity to local anaesthetics
Malignancy as a cause of shoulder pain
Evidence of significant progressive motor deficit
Fractures around shoulder and clavicle
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of ultrasound guided continuous supra scapular nerve block for chronic shoulder pain regarding the intensity of pain using NRS scale   Pain intensity assesment will be done pre-procedure ,immediate post-procedure,and at intervals of 5 days,2,4,12 and 24 weeks . 
 
Secondary Outcome  
Outcome  TimePoints 
To assess shoulder pain and range of motion by shouder pain and disability index (SPADI)
To determine patient satisfaction using Global perceived index (GPI) 
SPADI and GPI assesment Will be done pre-procedure ,immediate post-procedure,and at intervals of 5 days,2,4,12 and 24 weeks . 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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   N/A 
Date of First Enrollment (India)   08/01/2024 
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="0"
Months="0"
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  
  • Following approval from Institutional Ethical Committee, informed and written consent will be taken from 45 eligible patients who are hospitalized in JSSH for chronic shoulder pain. 
  • A thorough clinical evaluation with detailed shoulder examination will be performed by an experienced pain physician and Orthopedician. The diagnosis will be confirmed with USG/MRI findings of shoulder pathology concordant with the side of clinical features. The required investigations will be conducted and optimization of the comorbidities will be done before the procedure. 
  • 45 patients will be included in the single group and the baseline parameters will be noted. Suprascapular nerve Block (SSNB) on the affected side will be performed in the operating room under ultrasound guidance using standard ASA monitoring with ECG, HR, NIBP and SPO2.
  • Under strict aseptic precautions, patient will be placed in a sitting position with hand resting on the contralateral shoulder. SSNB will be performed by posterior approach. 
  • High frequency linear ultrasound probe (9 -11 HZ frequency, G E machine) will be placed in coronal plane in a short axis over the spine of the scapula with slight anterior tilt. Supraspinous fossa region is identified from medial to lateral to determine the boundaries formed by spine of scapula. Ultrasound probe is adjusted in a cephalocaudal direction to visualize the trapezius, supraspinatus muscle, superior transverse scapular ligament and suprascapular notch. Doppler is used to ensure the suprascapular artery and vein in the floor of fossa.
  •  After local skin infiltration with an injection 1% Lidocaine, 17G Tuhoy’s needle (VYGON-FRANCE) will be inserted in the longitudinal axis of the ultrasound beam using an in-plane approach from medial to the lateral direction. Needle is advanced further until the needle tip is in the proximity of suprascapular nerve below the distal fascial layer of the supraspinatus muscle. Needle tip position will be confirmed by hydro dissection using 0.5 ml NS. After confirmation of correct needle placement 6 ml of 0.25% injection bupivacaine + 1ml (4mg ) of injection of injection dexamethasone will be instilled after negative aspiration of blood, following which 19G catheter (VYGON-FRANCE) will be inserted through tuhoy’s needle. Correct placement of Catheter tip will be confirmed by adding additional 1 ml 0.25% bupivacaine. Tuohy’s needle is removed and after the tunneling of catheter, it will be fixed to the skin above the spine of scapula using a sterile dressing. 
  • Immediate post- procedure patient will be assessed for pain and disability scoring and then patient will be shifted to ward with instructions to start physiotherapy. 
  • Suprascapular catheter will be kept in situ for the next 5 days. During the hospital stay, 6 ml of 0.25% bupivacaine will be given through the catheter intermittently at the interval of 8 hours to reduce pain and to facilitate physiotheraphy. 
  • Patient is subjected to physiotherapy in the form of stretching and strengthening exercises to complete the full range of motion of shoulder joint. Flexibility exercises are done to achieve the activities of daily living. 
  • At the end of 5 days the patient will be discharged with advice to continue the home exercise program as advised by physiotherapy post-procedure.
  •  Patients will be followed up immediately post - procedure and at intervals of 5 days, 2, 4, 12 and 24 weeks for assessment of pain score using NRS, pain and functional status using SPADI, patient satisfaction using Global Perceived Index, and any side effects.

 
Close