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CTRI Number  CTRI/2024/10/074917 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Methods to Ease Shoulder Surgery Pain: Dry Stimulation vs. Continuous Pain Medicine 
Scientific Title of Study   Effectiveness of intermitent dry brachial plexus stimulation versus intermittent local anesthetic infusion of postoperative pain relief in patients undergoing shoulder surgery.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Diwan  
Designation  Senior Consultant  
Affiliation  Sancheti Institute of Orthopedics and Rehabiliation  
Address  operation theatre complex, Second floor, Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan1965@gmx.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Diwan  
Designation  Senior Consultant  
Affiliation  Sancheti Institute of Orthopedics and Rehabiliation  
Address  operation theatre complex, Second floor, Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan1965@gmx.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Diwan  
Designation  Senior Consultant  
Affiliation  Sancheti Institute of Orthopedics and Rehabiliation  
Address  operation theatre complex, Second floor, Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8484914584  
Fax    
Email  sdiwan1965@gmx.com  
 
Source of Monetary or Material Support  
NA  
 
Primary Sponsor  
Name  Sancheti Institute of Orthopedics and Rehabilitation 
Address  11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra, India 
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 Sandeep Diwan   Sancheti Institute of Orthopedics and Rehabiliation  Department of Anesthesiology, Operation theater, Second floor, Sancheti Hospital 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra, India Pune MAHARASHTRA Pune MAHARASHTRA
Pune
MAHARASHTRA 
8484914584

sdiwan1965@gmx.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Sancheti Institute of Orthopedics and Rehabilitation, e   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 
Comparator Agent  Dry stimulation  Dry stimulation of Interscalene catheter at 1MHz for 5mins every 6 hours for first 24 hours despite NRS values and Perineural injection of 0.2% ropivacaine 5ml whenever NRS 4 till 24 hours. 
Intervention  LOcal Anesthetic  Perineural injection of 0.2% ropivacaine 5ml whenever NRS 4 till 24 hours.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA-1 and undergoing shoulder surgery.  
 
ExclusionCriteria 
Details  1. The patients with chronic opioid use (more than 4 weeks), neuromuscular deficit within the operative extremity, implanted spinal cord stimulator, cardiac pacemaker/defibrillator deep brain stimulator, or other implantable neurostimulator.
2. The patients with chronic opioid use (more than 4 weeks), neuromuscular deficit within the operative extremity, implanted spinal cord stimulator, cardiac pacemaker/defibrillator
3. history of bleeding disorder; antiplatelet or anticoagulation therapies other than aspirin; allergy to local anesthetics will be excluded. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Local anesthetic consumption (0.2% ropivacaine) in 24 hours in both groups  Baseline and after 24 hrs postoperatively.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain scores as assessed by NRS in the postoperative period
2. NRS following stimulation in the dry stimulation group
3. Time to first LA bolus demand (NRS greater than 4)
4. Patient satisfaction with postoperative pain relief at end of 24 hrs
5. Any cardiorespiratory complications
 
Baseline and after 24 hrs postoperatively.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/10/2024 
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="1"
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  

Shoulder surgery frequently results in pain that is often difficult to manage with current analgesic options. Inadequate analgesia after shoulder surgery may lead to decreased range of motion, delay recovery, increase morbidity and lead to patient dissatisfaction. Moreover, a persistent acute pain may lead to chronic pain and narcotic dependence. 

 The most probable model involves “gate control” theory in which large-diameter afferent nerve fibers are stimulated, inhibiting the transfer of pain signals from small-diameter afferent fibers to the central nervous system at the level of the spinal cord. 

In recent years, the dry catheter technique of stimulating the brachial plexus without any drug delivery has been described in shoulder arthroplasty and has documented effective pain relief. However, there is a lack of trials comparing this technique with local anaesthetic infusion for postoperative pain in shoulder arthroplasty patients.

We hypothesised was that stimulation of brachial plexus in postoperative period may reduce the need of local anesthetic (LA) infusion and overall LA consumption.

Therefore, we planned this study to understand the postoperative block efficacy by stimulation of interscalene brachial plexus.

 
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