| CTRI Number |
CTRI/2022/02/040397 [Registered on: 17/02/2022] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Costoclavicular block in Frozen shoulder syndrome to produce analgesia |
|
Scientific Title of Study
|
Costoclavicular block in shoulder adhesive capsulitis- A clinical& Radiocontrast corelation assessing Analgesic efficacy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash Gaikwad |
| Designation |
Anaesthesiologist |
| Affiliation |
Sancheti institute of orthopaedics and rehabilitation |
| Address |
Anaesthesia department , first floor,OT complex, Sancheti hospital,shivaji nagar ,pune -05
Shivaji nagar, Pune- 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8007778750 |
| Fax |
|
| Email |
avipune22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avinash Gaikwad |
| Designation |
Anaesthesiologist |
| Affiliation |
Sancheti institute of orthopaedics and rehabilitation |
| Address |
Anaesthesia department, first floor, OT complex, shivaji nagar Pune
Shivaji nagar, Pune- 411005
Pune
MAHARASHTRA
411013
India |
| Phone |
8007778750 |
| Fax |
|
| Email |
avipune22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avinash Gaikwad |
| Designation |
Anaesthesiologist |
| Affiliation |
Sancheti institute of orthopaedics and rehabilitation |
| Address |
Anaesthesia department, first floor, OT complex,shivaji nagar Pune
Anaesthesia department, first floor, OT complexShivaji nagar, Pune- 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8007778750 |
| Fax |
|
| Email |
avipune22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti institute for orthopaedics and rehabilitation |
|
|
Primary Sponsor
|
| Name |
Sancheti institute for orthopaedics and rehabilitation |
| Address |
Shivaji nagar, Pune-411005 |
| 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 |
| Avinash Gaikwad |
Sancheti institute for orthopaedics and rehabilitation |
Anaesthesia department, Sancheti hospital ,shivaji nagar, Pune -411005
Pune
MAHARASHTRA |
8007778750
avipune22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,Sancheti institute for orthopaedics and rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costoclavicular Block in Shoulder Adhesive Capsulitis
A Clinical and Radiocontrast Corelation Assessing Analgesic Efficacy
|
Block Procedures will be performed in a dedicated block room.
Patient will be monitored with a multipara monitor and intravenous access will be obtained with a 22g canula. In the supine position the arm is adducted and a scout scan is performed to visualize the neural target and abnormal vascula-ture if any. A Dual guidance (USG + PNS) method is used to perform the costoclavicular block. The USG transducer probe is placed directly over the mid-point of the clavicle in the transverse orientation with its orientation marker directed medially (inward). Then the transducer is gently moved cau-dally until it slipped off the inferior border of the clavicle and the axillary ar-tery (first part) and vein were visualized. Maintaining the same transducer po-sition, it is gently tilted cephalad to direct the ultrasound beam toward the costoclavicular space. The ultrasound image is optimised until all 3 cords of the brachial plexus are clearly visualized lateral to the axillary artery. Using in plane approach, PNS needle is inserted from lateral to medial direction.
In conventional costoclavicular block the drug is deposited at two places, 1) at lateral cord & 2) between posterior cord and medial cord.
We aim to deposit 10ml at lateral cord and 10ml at the posterior cord. [since the shoulder innervation is chiefly from lateral and posterior cord below the clavicle] and by suprascapular nerve innervating 25% of shoulder joint origi-nating from superior trunk
Drugs : Inj. Ropivacaine (preservative free) (0.2%) 20ml + Inj.Triamcinolone acetonide 10mg + MRI contrast(Gadolinium based) 5 ml.
Total volume of 25 ml will be injected slowly in aliquots after con-firming negative aspiration of blood or air.
Post injection patient will be monitored in the recovery room for vital signs every 10min for 1hr.
Patients SPADI score will be evaluated at 1st hr by shoulder surgery resident.
Two hours later SPADI will be reassessed and a post block more than 50% reduction in shoulder pain will be taken as positive response. A clinical score would be assigned to the patient.
After surgeon has completed his clinical assessment, patient will be shifted to scan area for performing ipsilateral shoulder & neck area MRI scan. Radiolo-gist will evaluate the distribution and diffusion of contrast in the following are-as
1)suprascapular nerve above the clavicle;
2) lateral pectoral nerve
3) axillary nerve
4) subscapularis plane.
Based on the MRI findings a radiological score will be proposed.
Post scan the patient is discharged after fulfilling following criteria
1) no breathelessness,
2) no hypotension and tachycardia
3) no diaphgramatic paresis with real time ultrasound.
Further follow up of the patient will be done by shoulder surgeon and the con-cerned anaesthesiologist
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
BMI <25 |
|
| ExclusionCriteria |
| Details |
Patient with MRI noncompatible implant,
history of surgery of ipsilateral clavicle/ shoulder,
history of MRI contrast/ local anaesthetic drug allergy
COPD, PREGNANCY,Contralateral Phrenic nerve paresis, diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - To evaluate analgesic efficacy of costoclavicular block. Adequate analgesia will help patient to perform shoulder rehabilitation exercises efficiently. |
Post injection patient will be monitored in recovery room for vital signs every 10min for 1hr.
Patients SPADI score will be evaluated at 1st hr by shoulder surgery resident.
Two hours later SPADI will be reassessed and post block 50% reduc-tion in shoulder pain will be taken as positive response. A clinical score would be assigned to patient.
After surgeon finishes clinical assessment, patient will be shifted to scan area for performing ipsilateral shoulder & neck MRI scan. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To understand the spread of contrast with help of MRI images after costocla-vicular block
- To assess incidence of hemidiaphragmatic paresis.
|
2hr |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
28/02/2022 |
| 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="8"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shoulder adhesive capsulitis is characterised by stiff and painful shoulder joint. treatment options include oral analgesics, intraarticular steroid injections and physiotherapy exercises. Recently costoclavicular block was implemented as analgesic modality in shoulder arthroscopy surgery. we hypothesize that costoclavicular block can be used as analgesic modality in shoulder adhesive capsulitis so that after giving costoclavicular block, the analgesia produced will help patient to perform shoulder rehabilitation exercises efficiently |