| CTRI Number |
CTRI/2025/10/095570 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two techniques of Migraine treatment Nerve block through Nose Versus Ultrasound Guided injection |
|
Scientific Title of Study
|
Comparison of Transnasal Versus Ultrasound Guided Percutaneous Approach for Sphenopalatine Ganglion Block in Patients with Chronic Migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kartik Guleria |
| Designation |
Post Graduate Resident |
| Affiliation |
ABVIMS and Dr RML Hospital New Delhi |
| Address |
Room No 302 Third floor Academic Wing Department of Anesthesia ABVIMS and Dr RML Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
8544760568 |
| Fax |
|
| Email |
kartikguleria251@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Gupta |
| Designation |
Director Professor |
| Affiliation |
ABVIMS and Dr RML Hospital New Delhi |
| Address |
Room No 302 Third floor Academic Wing Department of Anesthesia ABVIMS and Dr RML Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Gupta |
| Designation |
Director Professor |
| Affiliation |
ABVIMS and Dr RML Hospital New Delhi |
| Address |
Room No 302 Third floor Academic Wing Department of Anesthesia ABVIMS and Dr RML Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
9810685426 |
| Fax |
|
| Email |
drakhileshgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi 110001 New Delhi |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia ABVIMS and Dr RML Hospital New Delhi 110001 |
| 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 Kartik Guleria |
ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi |
Room No 302 Third floor Academic Wing Department of Anesthesia ABVIMS and Dr RML Hospital New Delhi 110001
Central
DELHI |
8544760568
kartikguleria251@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comimittee ABVIMS and Dr RML Hospitall,New Delhi |
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 |
Sphenopalatine Ganglion Block |
Comparison of Transnasal approach vs Ultrasound guided percutaneous approach for Sphenopalatine ganglion block in patients with chronic migraine by assesing the number of headaches 1 month post procedure upto 3 months |
| Intervention |
Transnasal approach for Sphenopalatine ganglion block |
It is a minimally invasive method involving administration of local anesthetic through nasal cavity |
| Intervention |
Ultrasound Guided Percutaneous
approach for Sphenopalatine Ganglion Block |
This technique implies real time imaging to visualize anatomical landmarks and guide needle placement in Sphenopalatine Ganglion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Chronic migraine according to ICHD-3 Criteria
2. Patient without any secondary headaches. |
|
| ExclusionCriteria |
| Details |
1. Patients who had a history of trauma or surgery involving the head and neck area with any etiology.
2. Patients who had any anatomical deformation that disrupted the head and neck contour
3. Patients with a history of severe psychiatric illness.
4. Patients with possible tooth and palate pathologies which are detected with detailed evaluation by the Dentist and Ent specialists.
5. Presence of Secondary Headache Aetiology (tumour , bleeding , stroke).
6. History of any Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of Headaches post procedure monthly upto 3 months |
1st month 2nd month 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of pain by NRS in most severe headache in 1 month post procedure evaluated upto 3 months. |
1st month 2nd month & 3rd month |
| Impact of headache using HIT6 score at pre procedure & post procedure monthly upto 3 months |
1st month 2nd month 3rd month |
| Impact of headache using MIDAS score at pre procedure level & at 3rd month post procedure. |
1st month 3rd month |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/10/2025 |
| 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="1"
Days="19" |
|
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 involves two groups of patients undergoing sphenopalatine ganglion (SPG) block after obtaining informed consent. In Group 1, patients receive a transnasal SPG block in the supine position with mild neck extension. A long-tipped cotton applicator soaked with 0.5 ml of 2% lidocaine is advanced transnasally to the posterolateral surface of the nasopharynx at the level of the middle turbinate. In Group 2, patients undergo an ultrasound-guided percutaneous SPG block under sterile conditions without sedation, using only local anesthesia. A high-frequency linear ultrasound probe (10–15 MHz) is placed transversely above the zygomatic arch and anterior to the temporal fossa to identify key landmarks, including the maxilla, zygomatic arch, temporal fossa, and the pterygopalatine fossa. Under real-time ultrasound guidance, a needle is advanced carefully, avoiding vascular structures, and hydrodissection may be performed to confirm precise tissue plane entry. Once non-vascular placement is confirmed, 1.5–3 ml of either 0.25–0.5% bupivacaine or 2%lidocaine with or without steroid, is injected to achieve blockade. All patients are monitored and followed up at one, two, and three months after the procedure. |