| 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
|
|
|
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
|
|
|
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. |