| 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
|
|
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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
|
|
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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 . |
|
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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
|
|
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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.
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