| CTRI Number |
CTRI/2026/01/102286 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study comparing effectiveness of nasal nerve block for treating facial pain not responding to medications using local anaesthetic , local anaesthetic with steroid versus placebo |
|
Scientific Title of Study
|
Comparison of Sphenopalatine ganglion block efficacy via transnasal approach using lignocaine , lignocaine with dexamethasone versus placebo in patients of trigeminal neuralgia refractory to pharmacotherapy- A Prospective Randomized control trial |
| Trial Acronym |
SPG-TREAT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kritika Mani |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences (IMS),Banaras Hindu University (BHU) |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
(IMS),Banaras Hindu University (BHU) Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7233022589 |
| Fax |
|
| Email |
kritikamani122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Prakash |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences (IMS),Banaras Hindu University (BHU) |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
(IMS),Banaras Hindu University (BHU) Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453047154 |
| Fax |
|
| Email |
dr.shashi.prakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratima Rathore |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences (IMS),Banaras Hindu University (BHU) |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
(IMS),Banaras Hindu University (BHU) Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7838660734 |
| Fax |
|
| Email |
pratima.lhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University Varanasi, Uttar Pradesh, India Pin-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology,
Institute of Medical Sciences, Banaras Hindu University Varanasi India 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 Kritika Mani |
Institute of Medical Sciences, Banaras Hindu University |
Sir Sundarlal Hospital, Department of Anaesthesiology
Varanasi
UTTAR PRADESH |
7233022589
kritikamani122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
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 |
| Intervention |
Lignocaine 4 percent |
Group L: patients will undergo transnasal Sphenopalatine ganglion block with 2 ml lignocaine 4% and 1 ml normal saline. 3 times application in interval of 24 hours will be done and patient to be followed up till 2 weeks. |
| Comparator Agent |
Lignocaine 4 percent plus dexamethasone |
Group D:Patients will undergo similar procedure and receive SPG block with Lignocaine 4% ( 2 ml )+ 4 mg Dexamethasone (1 ml). 3 times application in interval of 24 hours will be done and patient to be followed up till 2 weeks. |
| Comparator Agent |
Normal saline (placebo) |
Group C : Placebo group,
patients will undergo transnasal SPG block with 3 ml normal saline. 3 times application in interval of 24 hours will be done and patient to be followed up till 2 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of trigeminal neuralgia refractory to pharmacotherapy having severe pain belonging to ASA physical status I-III. |
|
| ExclusionCriteria |
| Details |
1.Patients undergone previous treatment with Radiofrequency ablation.
2.Any diagnosed/known vascular lesion and anatomical deformity of nose or fracture on affected side.
3. Active nasal discharge.
4. Patients with any other painful conditions for which patients is on analgesic medication.
5.pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain intensity using NRS and duration of analgesia post procedure |
At Baseline ,1 week and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction in frequency of attacks 12 hourly
2.Daily Rescue analgesic requirement till discharge
3.Improvement in Quality of life score and patients satisfaction score.
|
At discharge, 1 week and 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/02/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kritikamani122@gmail.com].
- For how long will this data be available start date provided 09-02-2026 and end date provided 09-02-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patient will be randomized using SNOSE technique (Sequentially numbered opaque sealed envdelopes) into following three groups Group L Sphenopalatine ganglion block( SPG) via transnasal approach using 2 ml lignocaine 4 percent and 1 ml normal saline Group D SPG block with lignocaine 4 percent and 4 mg dexamethasone 1 ml Group C Placebo group that is 3 ml normal saline Patient will be assessed at 15 mins 30 mins 1 hour 6 hours 12 hours 24 hours 36 hours 48 hours and at discharge for pain score (NRS score) blood pressure pulse rate spo2 and any adverse events . In case of NRS more than 4 rescue analgesia will be administered to all groups Frequency of attacks per day will be recorded 12 hourly till discharge Patients follow up will be done at 1 week interval for next 2 weeks and will be asked to maintain pain diary and continue their medical therapy they are on. In case of no improvement in pain score patient will be send for standard therapy |