CTRI Number |
CTRI/2025/04/085036 [Registered on: 17/04/2025] Trial Registered Prospectively |
Last Modified On: |
17/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [two nerve blocks] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparing Two Nerve Block Techniques for Treating Chronic Refractory Migraine: A Clinical Trial |
Scientific Title of Study
|
Comparative evaluation of Ultrasound guided stellate ganglion versus sphenopalatine ganglion blockade for the treatment of patients with chronic refractory migraine: an open label randomized controlled 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 |
Prof Dr Ajit Kumar |
Designation |
Professor |
Affiliation |
All India Institute of medical sciences Rishikesh |
Address |
Department of Anesthesiology
AIIMS Rishikesh Uttarakhand 249202
Dehradun UTTARANCHAL 249202 India |
Phone |
9910789377 |
Fax |
|
Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr Ajit Kumar |
Designation |
Professor |
Affiliation |
All India Institute of medical sciences Rishikesh |
Address |
Department of Anesthesiology
AIIMS Rishikesh Uttarakhand 249202
Dehradun UTTARANCHAL 249202 India |
Phone |
9910789377 |
Fax |
|
Email |
ajitdr.ajit@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof Dr Ajit Kumar |
Designation |
Professor |
Affiliation |
All India Institute of medical sciences Rishikesh |
Address |
Department of Anesthesiology
AIIMS Rishikesh Uttarakhand 249202
Dehradun UTTARANCHAL 249202 India |
Phone |
9910789377 |
Fax |
|
Email |
ajitdr.ajit@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of medical sciences, Rishikesh |
|
Primary Sponsor
|
Name |
Dr Ajit Kumar |
Address |
Department of anesthesiology
Aiims rishikesh Uttarakhand India 249202 |
Type of Sponsor |
Research institution |
|
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 Ajit Kumar |
aiims rishikesh |
department of anesthesiology aiims Rishikesh Uttarakhand Dehradun UTTARANCHAL |
9910789377
ajitdr.ajit@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, (2) ICD-10 Condition: G437||Chronic migraine without aura, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Ultrasound Guided Sphenopalatine Ganglion Block
|
Patients were sedated and positioned with the head turned to the opposite side using a linear ultrasound probe placed infrazygomatically a 25 gauge needle was inserted out of plane through the pterygomaxillary fissure into the pterygopalatine fossa after confirming correct placement 6 mL of 0 point 15 percent ropivacaine was injected and the spread was visualized on ultrasound duration 30 minutes |
Comparator Agent |
Ultrasound Guided Stellate Ganglion Block |
After preoperative workup and sedation with midazolam and fentanyl patients were positioned supine and the neck area was prepared under sterile conditions using a high frequency linear ultrasound probe the stellate ganglion at the C6 level was identified an in plane technique was used to advance the needle to the prevertebral fascia over the Longus colli muscle avoiding vascular and neural structures after confirming negative aspiration 5 mL of 0 point 15 percent ropivacaine was injected under real time ultrasound guidance duration 30 minutes |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Age between 18 and 60 years
Diagnosed with migraine by expert physicians
Diagnoses made according to International Classification of Headache Disorders criteria
Pain unresponsive to conservative treatment including medical management physical therapy and previous interventions
Average pain score of 4 or more on an 11 point Numerical Rating Scale
Competent to understand the study protocol willing to provide voluntary written informed consent and willing to participate in the assessment of outcome measurements |
|
ExclusionCriteria |
Details |
Patient refusal
Pain for less than 6 months
Patients with a space occupying lesions in radiological investigations CT or MRI
Patients with bilateral migraine attacks
Coagulopathy and or patients on anticoagulants.
Infection at the site of injection.
Hypersensitivity to local anesthetic agent.
Evidence of severe psychiatric illness.
Uncontrolled or unstable opioid use
Any conditions that might compromise the interpretation of outcome assessments.
Pregnancy or lactation.
History of any major comorbid medical conditions those interfere with recording of study outcomes neurological disorders auto-immune diseases multiple sclerosis.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Pain relief as assessed by Migraine disability assessment score MIDAS Annexure I at baseline and at 3 months after the procedure |
at baseline and at 3 months after the procedure |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain relief as assessed by Numerical Rating Scale NRS on a scale of 1 to 10
Analgesic usage Procedural complications if any
|
at baseline 1 month and at 3 months after the procedure |
|
Target Sample Size
|
Total Sample Size="502" Sample Size from India="502"
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 3 |
Date of First Enrollment (India)
|
28/04/2025 |
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="1" |
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
|
This open-label randomized controlled trial aims to compare the clinical effectiveness of ultrasound-guided stellate ganglion block versus ultrasound-guided sphenopalatine ganglion block in patients with chronic refractory migraine. Patients aged 18 to 60 years who meet the International Classification of Headache Disorders ICHD criteria and have not responded to conservative treatments will be enrolled. Participants will be randomized into two groups receiving either stellate or sphenopalatine ganglion blockade under ultrasound guidance. The primary outcome will be reduction in pain intensity measured on the Numerical Rating Scale NRS. Secondary outcomes will include frequency and duration of migraine episodes and assessment of adverse events. This study will help determine the more effective interventional approach for managing chronic refractory migraine. |