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CTRI Number  CTRI/2025/12/098682 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   “Understanding Long-Term Nerve Pain After Surgery for Brachial Plexus Injuries in Adults” 
Scientific Title of Study   Incidence of Neuropathic Pain in Operated Traumatic Brachial Plexus Injury in Adults: A Long-Term Follow-up 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  voggu venkata vinay vivek 
Designation  Senior resident 
Affiliation  Department of Hand surgery,Kasturba Medical College,Manipal 
Address  Department of Hand surgery,Kasturba Medical College,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9985947954  
Fax    
Email  orthodoctorvinay@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR ASHWATH ACHARYA 
Designation  PROFESSOR AND HEAD 
Affiliation   
Address  Department of Hand surgery,Kasturba Medical College,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9985947954  
Fax    
Email  orthodoctorvinay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  voggu venkata vinay vivek 
Designation  Senior resident 
Affiliation  Department of Hand surgery,Kasturba Medical College,Manipal 
Address  Department of Hand surgery,Kasturba Medical College,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9985947954  
Fax    
Email  orthodoctorvinay@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India 
 
Primary Sponsor  
Name  voggu venkata vinay vivek 
Address  Department of Hand surgery,Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India 
Type of Sponsor  Other [Self(Primary Investigator)] 
 
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 
voggu venkata vinay vivek  Kasturba Medical College  Department of Hand surgery,Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104, India
Udupi
KARNATAKA 
09985947954

orthodoctorvinay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Kasturba Medical College & Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S143||Injury of brachial plexus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All operated Adult Traumatic brachial plexus injury
Age range of 15-65 years old
Diagnosed as TBPI by history, physical examination, electromyography and the
surgical exploration 
 
ExclusionCriteria 
Details  Medical management
diagnosed with any other disease that may cause neuropathic pain.
primary nerve surgery performed greater than one year since injury 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain Intensities
Pain Symptoms
Pain Locations 
At this cross section past 2years since surgery how are the pain parameters is analysed 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  At this cross section past 2years since surgery how is the quality of life of patient is analysed 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   19/12/2025 
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="2"
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  

The study is titled Incidence of Neuropathic Pain in Operated Traumatic Brachial Plexus Injury in Adults A Long-Term Follow-up.

Traumatic brachial plexus injuries cause severe disability and neuropathic pain is a common complication. The prevalence and long-term characteristics of neuropathic pain after nerve reconstruction surgery are not well documented. This prospective observational study aims to evaluate its incidence, severity, and impact.

Earlier studies reported neuropathic pain in 50 to 76 percent of patients with brachial plexus injuries. Factors such as nerve avulsion, alcohol, smoking, and severity of injury are associated with higher risk. Neuropathic pain negatively affects quality of life and mood.

The aim of the present study is to evaluate the incidence and characteristics of neuropathic pain in adult patients who underwent nerve reconstruction for traumatic brachial plexus injury with at least two years of follow-up. The primary objective is to assess demographic and injury characteristics of patients with neuropathic pain. Secondary objectives are to measure pain severity using the DN4 scale, characterize pain using the Brief Pain Inventory Short Form and the Neuropathic Pain Symptom Inventory, and evaluate functional performance using the Australian modified Karnofsky Performance Scale.

The study design is prospective observational. The sample size is 48, calculated based on a prevalence of 69 percent with adjustment for dropout. Inclusion criteria are adults aged 15 to 65 years with surgically treated traumatic brachial plexus injury confirmed by history, examination, electromyography, and surgical exploration. Exclusion criteria include medical management only, comorbid diseases that may cause neuropathic pain, and primary surgery performed more than one year after injury.

Patients will undergo baseline and follow-up evaluations using DN4, BPI-SF, AKPS, NPSI, and visual analog scale for pain. Pain intensity, symptoms, and location will be assessed longitudinally. Surgical interventions include exploration and reconstruction with nerve grafts and transfers.

Statistical analysis will be done using SPSS version 23 with chi square for categorical variables and t test or ANOVA for grouped variables. A p value less than 0.05 will be considered significant.

 
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