| 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
|
|
|
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
|
|
|
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
|
|
|
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. |