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CTRI Number  CTRI/2024/02/062486 [Registered on: 09/02/2024] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To see effectiveness of Ultrasound guided Glossopharyngeal Nerve block technique 
Scientific Title of Study   Evaluation of Ultrasound guided Glossopharyngeal Nerve Block Technique 
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 Sujeet Kumar Singh Gautam 
Designation  Professor 
Affiliation  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  Department of Anaesthesiology, A Block, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904046  
Fax    
Email  docsksg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujeet Kumar Singh Gautam 
Designation  Professor 
Affiliation  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  Department of Anaesthesiology, A Block, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904046  
Fax    
Email  docsksg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ayushi Bansal 
Designation  Junior Resident 
Affiliation  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  Department of Anaesthesiology, A Block, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004967783  
Fax    
Email  ayushibansal35004@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institute of Medical Sciences 
 
Primary Sponsor  
Name  Sanjay Gandhi Post-graduate Institute of Medical Sciences 
Address  SGPGIMS, Raibareli Road, Lucknow-226014 
Type of Sponsor  Research institution and hospital 
 
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 Sujeet Kumar Singh Gautam  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Anaesthesiology, A BLock, Old OPD
Lucknow
UTTAR PRADESH 
87659740464046

docsksg@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: G521||Disorders of glossopharyngeal nerve,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NA 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed with primary glossopharyngeal neuralgia not responding to medical management will be included in the present study. 
 
ExclusionCriteria 
Details  1. Patients with cardiopulmonary diseases such as myocardial infarction, and heart failure
2. Patients with mental disorders, local infection, or pregnancy
3. Patients with abnormal coagulation function
4. Patients with history of snoring. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SEVERITY OF PAIN  Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage pain relief  Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure 
Reduction of analgesic usage  Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure 
Psychological assessment of patient by using DSM-IV scale  Baseline, 2 hours after the procedure, 2 weeks, 1, 3- and 6-months post-procedure 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2024 
Date of Study Completion (India) 31/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  
Title: Evaluation of Ultrasound Guided Glossopharyngeal Nerve Block Technique Glossopharyngeal
neuralgia, also known as vagal glossopharyngeal neuralgia, is characterized by intermittent episodes
of shooting sharp pain in the jaw, throat, tongue, and ear that fall within the sensory distribution of
the glossopharyngeal nerve (cranial nerve IX) Inclusion criteria: Patients (more than 18 years of age)
diagnosed with primary glossopharyngeal neuralgia not responding to medical management will be
included in the present study. Exclusion criteria: 1. Patients with cardiopulmonary diseases such as
myocardial infarction, and heart failure 2. Patients with mental disorders, local infection, or
pregnancy 3. Patients with abnormal coagulation function 4. Patients with history of snoring.
POSITION- Patient lying in the lateral position with a thin pillow under the head. Area between
mastoid process and angle of mandible will be scanned with high-frequency (13-6 MHz) linear array
hockey stick probe to locate styloid process. Colour flow dopler will be used to identify the internal
carotid artery and the internal jugular vein. A needle will be directed in an in plane approach
towards the styloid process; which will be hit and the needle slid posteriorly and 2 ml 1% lidocaine +
4 mg dexamethasone injected.Positive response - > 50% reduction NRS scores for at least 2 hours
following injection; patients having a positive response will be followed for 6 months.A combination
of acetaminophen (325mg) and tramadol (37.5mg) will be prescribed for 5 days post-procedure and
patient advised to take the same if NRS will be >3 and on SOS basis during follow up. Repeat block
will be performed if severity of pain increased to NRS of > 5 or pain relief decreased to less than
50%. PRIMARY Severity of pain on the basis of NRS Score SECONDARY Percentage pain relief
Reduction of analgesic usage, and psychological assessment of patient by using DSM-IV scale All
these assessments will be done before the procedure (baseline), 2 hours after the procedure, 2
weeks, 1, 3- and 6-months post-procedure; the patient assessment between 2 weeks to 6 months of
follow up will be done by telephonic communication SAMPLE SIZE- Using Wilcoxon signed rank test
(matched pair) for one tail (as score will reduce) and effect size 1, 15 cases are required.
Considering design effect (1.5) and 10% lost to follow up final sample size will be 25. STATYSTICAL
ANALYSIS- Paired t-test will be used to compare pre and post-treatment results of NRS scores;
McNemar test will be used to compare pre and post- treatment results of percentage pain relief and
reduction of analgesic dose; Wilcoxon signed rank test will be used for the comparison of DSM-IV; P
value < 0.05 will be considered as significant.
 
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