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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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