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CTRI Number  CTRI/2023/07/055440 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Is there any difference between short axis and combined short and long axis approach of median nerve hydrodissection in patients of carpal tunnel syndrome? 
Scientific Title of Study   A Randomised controlled study comparing short axis and combined short and long axis median nerve hydrodissection for carpal tunnel syndrome  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Bhardwaj 
Designation  First year resident 
Affiliation  Lady Hardinge Medical College  
Address  Department of Anesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi , 110001

Central
DELHI
110001
India 
Phone  8708770291  
Fax    
Email  sakshirules12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nitin Hayaran  
Designation  Professor  
Affiliation  Lady Hardinge Medical College  
Address  Department of Anesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi

Central
DELHI
110001
India 
Phone  9873903603  
Fax    
Email  nhayaran97@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sakshi Bhardwaj  
Designation  First year resident  
Affiliation  Lady Hardinge Medical College  
Address  Department of Anesthesia, Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi

Central
DELHI
110001
India 
Phone  8708770291  
Fax    
Email  sakshirules12@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi, 110001  
 
Primary Sponsor  
Name  Lady Hardinge Medical College and associated hospitals 
Address  Shaheed Bhagat Singh Road, Connaught Place , New Delhi , 11001 
Type of Sponsor  Government 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 Sakshi Bhardwaj   Lady Hardinge Medical College and associated hospitals   Department of Anesthesia, Pain Clinic, Smt Sucheta Kriplani Hospital, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place , New Delhi, Central Delhi , 110001
Central
DELHI 
8708770291

sakshirules12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G560||Carpal tunnel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group B - Combined short and long axis approach.  Group B - Patients in group B will be subjected to ultrasound guided median nerve hydrodissection using combined short and long axis approach. 
Comparator Agent  Hydrodissection using short axis approach   Hydrodissection using combined short and long axis approach  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All adult patients diagnosed with Carpal Tunnel Syndrome based on clinical criteria and Nerve Conduction Velocity studies. 
 
ExclusionCriteria 
Details  1) A previous history of wrist surgery,polyneuropathy,brachial plexopathy, or thoracic outlet syndrome.
2) Previous steroid injection for Carpal Tunnel Syndrome in the last 3 months.
3) Patients with grade 5 and grade 6 Carpal Tunnel Syndrome according to Blands neurophysiological grading of carpal tunnel syndrome. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage change in median Boston Carpal Tunnel Severity Questionnaire (BCTSQ) score at 3 months from baseline after ultrasound guided hydrodissection of median nerve in both the groups.  At baseline and at the end of 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Change in the mean cross sectional diameter of the median nerve calculated using ultrasonographic evaluation in both the groups at the end of 3 months.  At the end of 3 months  
Difference in median Nerve Conduction Velocity (NCV) grade in both the groups at the end of 3 months.  At the end of 3 months  
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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 3/ Phase 4 
Date of First Enrollment (India)   28/07/2023 
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="1"
Months="3"
Days="10" 
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  

Study will be conducted after the approval by the Institutional Ethics Committee and will be registered in the Clinical Trials Registry- India (CTRI).  Patients will be chosen for the study keeping in mind the inclusion and exclusion criteria. A careful checkup including detailed history with special emphasis on characteristic signs and symptoms of CTSphysical examination, clinical tests which include provocative maneuvers like Phalen test, Tinel testDurkan test, Upper limb neurodynamic test, hand elevation test and electrodiagonostic test(NCV) will be done. Patients will be classified on the basis of Blands neurophysiological grading of CTS 12 (Annexure – IV). A written informed voluntary consent will be taken from the patient after carefully explaining the procedure, its benefits and risks and alternative therapies in patient’s own language. Median nerve diameter will be assessed in all the patients using ultrasonographic evaluation. All patients will be explained about the Boston Carpal Tunnel Severity Questionnaire (BCTSQ, Annexure – III). Baseline BCTSQ score will be taken in patients before procedure. Patients will be shifted to procedure room and standard monitoring will be applied, including pulse oximetery, electrocardiography and noninvasive blood pressure.

Randomisation

An investigator with no further involvement in the study will generate a list ofrandom numbers between 01-100 in varying block sizes using an online computer randomization service (Research Randomizer www.Randomizer.org). The unique randomization code will be allocated and used to randomize consenting participant patients equally with no restrictions or bias to either of the two study groups: short axis group (A) or combined short and long axis group (B).

​

Allocation Concealment   

The results of the allocation will be concealed in sequentially numbered sealed opaque envelopes mentioning the code and group number . These envelopes with results of allocation will not be seen by the research coordinator prior to sealing and will only be kept by the coordinator after sealing. On the day of procedure, the coordinator will hand over an envelope to the principal investigator. The approach for the procedure will be decided by the group mentioned in the envelope. Case record sheet filled subsequently will only mention the randomized code with no reference to the approach or group number noted.

For group A (Short axis approach) - The needle and probe are both perpendicular to the nerve. The needle is in plane to the transducer and the soft tissues below the nerve are first hydrodissected (with the needle bevel facing up) followed by hydrodissection of soft tissues above the nerve (with the needle bevel facing down).

 

For group B (Combined short and long axis approach) - First the needle and probe are both perpendicular to the nerve and hydrodissection is done similar to the short axis approach. Subsequently both the transducer and needle are turned parallel to the nerve and soft tissue below and above the nerve are hydrodissected. This allows us to hydrodissect a long segment of the nerve in both proximal and distal direction.

 

The injectate used in both the situations is 20ml of 5% dextrose with water.

 

Serious adverse events (such as swelling, pain, bleeding, increased paresthesia or numbnessinjury to neighbouring neurovascular structures) will be noted, managed and reported to the IEC within 24 hours.

 
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