| CTRI Number |
CTRI/2025/05/087552 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Any additional pain relief in Trigeminal neuralgia patients with use of local anesthetic injection along with carbamazepine tablets |
|
Scientific Title of Study
|
Evaluation of Efficacy of Peripheral Nerve Blocks as an add on
therapy to Carbamazepine in Trigeminal Neuralgia A Randomized
control Trial |
| 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 Jyoti Bhatt |
| Designation |
Post Graduate Student |
| Affiliation |
|
| Address |
Room No 11 Department of Oral Medicine and Radiology Post Graduate Institute of Dental Sciences Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416649651 |
| Fax |
|
| Email |
jyotibhatt84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lavina Arya |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Room No 11 Department of Oral Medicine and Radiology Post Graduate Institute of Dental Sciences Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9212795285 |
| Fax |
|
| Email |
aryalavina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Bhatt |
| Designation |
Post Graduate Student |
| Affiliation |
|
| Address |
Room No 11 Department of Oral Medicine and Radiology Post Graduate Institute of Dental Sciences Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416649651 |
| Fax |
|
| Email |
jyotibhatt84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Dental Sciences Rohtak 124001 Haryana India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Jyoti Bhatt |
Post Graduate Institute of Dental Sciences Rohtak |
Room No 11 Department of Oral Medicine and Radiology Post Graduate Institute of Dental Sciences Rohtak 124001 Haryana India
Rohtak
HARYANA |
9416649651
jyotibhatt84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL AND HEALTH RESEARCH ETHICS COMMITTEE PGIDS ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G440||Cluster headaches and other trigeminal autonomic cephalgias (TAC), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CARBAMAZEPINE PLUS DISTILLED WATER |
Distilled water injection will be given once a week for four weeks in involved branch along with 100 mg Carbamazepine BD which will be increased or decreased as per patient need till 3 months |
| Intervention |
CARBAMAZEPINE PLUS PERIPHERAL NERVE BLOCK |
2 percent Lignocaine peripheral nerve block will be given in involved branch once a week for four weeks along with 100 mg Carbamazepine BD which will be increased or decreased as per patient need till 3 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Classical and Idiopathic Neuralgia
Newly diagnosed Trigeminal Neuralgia patients or with remission of 1 months or more
Patient consent for participation in this study |
|
| ExclusionCriteria |
| Details |
Secondary Trigeminal Neuralgia patients
Patients on anti psychotics
History of excessive alcohol intake
Hepatic or renal insufficiency
Known tolerance or allergy to study drug
Pregnancy or Lactation
Non compliant during screening period
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Numeric Pain Rating Scale (NPRS) assessment of pain |
0 1 2 3 weeks 1 month 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate mean dose of carbamazepine used in both the groups
2 To evaluate number of responders with 50 percent relief in pain.
3 LIKERTs scale for assessment of quality of life
4 LIKERTs scale for Patient Satisfaction
5 Adverse effects as reported by the patient |
0 1 2 3 weeks 1 month 3 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/07/2025 |
| 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="1"
Months="6"
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
|
Trigeminal neuralgia is a chronic type of neuropathic pain characterized by paroxysmal electric shock like pain that affects the individuals quality of life to a great extent Carbamazepine being the first line of drug for trigeminal neuralgia is primarily prescribed to the patient But due to its vast number of side effects it Is not well tolerated by the patient as dose increases Since it Is an excruciating pain condition there is need to explore more treatment modalities helping in attaining better pain relief There are few studies regarding use of Peripheral Nerve Blocks and Trigger zone injections with local anaesthetics along with routine drug therapy in refractory cases of Trigeminal Neuralgia patients with good results Its efficacy has been established in acute exacerbations of Trigeminal Neuralgia Lignocaine is being widely used in dentistry in topical as well as injectable form to treat several acute and chronic pain conditions with minimal adverse effects Performing lignocaine nerve blocks is a routine in office procedure in dental clinics More over to the best of our knowledge till now no studies have evaluated the therapeutic effectiveness and synergistic effect of 2 percent Lignocaine nerve blocks in routine management of Trigeminal Neuralgia patients The aim of the present study is to bridge that gap in literature and to evaluate the efficacy of this multimodal treatment strategy in trigeminal neuralgia patients
|