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CTRI Number  CTRI/2019/01/017154 [Registered on: 18/01/2019] Trial Registered Prospectively
Last Modified On: 17/01/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Management of severe facial pain using nerve block technique.  
Scientific Title of Study   Feasibility and efficacy of ultrasound-guided trigeminal nerve block via pterygopalatine fossa for the management of refractory idiopathic trigeminal neuralgia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neerja Bharti 
Designation  Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive care, PGIMER
NA
Chandigarh
CHANDIGARH
160012
India 
Phone  9915575145  
Fax    
Email  bhartineerja@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neerja Bharti 
Designation  Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive care, PGIMER
NA
Chandigarh
CHANDIGARH
160012
India 
Phone  9915575145  
Fax    
Email  bhartineerja@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neerja Bharti 
Designation  Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive care, PGIMER
NA
Chandigarh
CHANDIGARH
160012
India 
Phone  9915575145  
Fax    
Email  bhartineerja@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh  
 
Primary Sponsor  
Name  PGIMER Chandigarh  
Address  Sector-12, Chandigarh  
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 Neerja Bharti  Post Graduate Institute of Medical Education and Research   Department of Anaesthesia and Intensive Care, Nehru hospital, Post Graduate Institute of Medical Education and Research, Sector -12 Chandigarh CHANDIGARH Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH 
9915575145

bhartineerja@yahoo.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: G518||Other disorders of facial nerve,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None (single arm study)  Not applicable 
Intervention  Trigeminal nerve block  Injection of 4 mL of bupivacaine 0.25%, and 40 mg of triamcinolone on the side of the face just below the zygomatic bone in the pterygopalatine fossa using ultrasound guidance by an experienced anaesthesiologist under all aseptic precautions and standard monitoring of ECG, blood pressure and pulse oximetry. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  40 consecutive adult patients of idiopathic trigeminal neuralgia resistant to pharmacological treatment will be included

 
 
ExclusionCriteria 
Details  Allergy to local anesthetics or steroids, infection, coagulopathy, and pregnancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients will be asked to rate their 24-hour global pain experience including severity, duration, frequency of the episodes, and to report it as a percentage of global pain relief   at 2 weeks, 1 month, 2 month and 3 months after procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Duration of procedure, complications and success rate  during and after the procedure and at 1, 2 and 3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   19/01/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Trigeminal neuralgia (TGN) is characterized by the sudden onset of recurrent severe pain in trigeminal nerve distribution. The condition is severely disabling with impaired quality of life. Idiopathic TGN is difficult to treat by medications and interventional therapy may be required in 25-30% of patients. Trigeminal nerve block is usually performed for the relief of severe refractory pain of TGN by using landmark technique or under fluoroscopy guidance. The ultrasound-guided trigeminal nerve block via pterygopalatine fossa has been demonstrated in few case reports and found to be effective in patients with refractory trigeminal neuralgia and atypical facial pain. Therefore, the present study has been planned to evaluate the feasibility and effectiveness of ultrasound-guided trigeminal nerve block via pterygopalatine fossa for the management of idiopathic trigeminal neuralgia. In this study, 40 consecutive patients of refractory trigeminal neuralgia will receive trigeminal nerve block with 4 mL of bupivacaine 0.25% and 40 mg triamcinolone in the pterygopalatine fossa using ultrasound guidance. The patients will be followed up for 3 months to assess global pain relief and reduction in analgesic medications. Any adverse effect, patients’ satisfaction, and the number of patients having effective pain relief for 3 months will be recorded.

 
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