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CTRI Number  CTRI/2018/01/011494 [Registered on: 23/01/2018] Trial Registered Prospectively
Last Modified On: 19/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Interventional Management of Trigeminal Neuralgia 
Scientific Title of Study   Comparison of Percutaneous Radiofrequency Thermocoagulation and Percutaneous Microballoon Compression of Gasserian ganglion in Treatment of Trigeminal neuralgia- A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Virender Kumar Mohan 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room No 5007 5th Floor Teaching Block AIIMS Ansari Nagar New Delhi 110029

South
DELHI
110029
India 
Phone    
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Virender Kumar Mohan 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room No 5007 5th Floor Teaching Block AIIMS Ansari Nagar New Delhi 110029


DELHI
110029
India 
Phone    
Fax    
Email  dr_vkmohan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Virender Kumar Mohan 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Room No 5007 5th Floor Teaching Block AIIMS Ansari Nagar New Delhi 110029


DELHI
110029
India 
Phone    
Fax    
Email  dr_vkmohan@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi Department of Anaesthesiology, Pain Medicine and Critical Care Room No-5011, 5th Floor, Teaching Block All India Institute of Medical Sciences, New Delhi-110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Department of Anaesthesilogy, Pain Medicine and Critical Care AIIMS New Delhi 
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 Virender Kumar Mohan  AIIMS New Delhi  Room No 50011 5th Floor Teaching Block AIIMS Ansari Nagar New Delhi 110029
South
DELHI 		 9868397803

dr_vkmohan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA I and II patients with unilateral trigeminal neuralgia ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison of Percutaneous Radiofrequency Thermocoagulation and Percutaneous Microballoon Compression of Gasserian ganglion in Treatment of Trigeminal neuralgia  Both the procedure would be done under flouoroscopy guidance Percutaneous radiofrequency thermocoagulation would be done under sedation while percutaneous micro-balloon compression would be done under general anaesthesia 
Comparator Agent  Percutaneous Micro-Balloon Compression (PMBC)   The procedure is done under general anaesthesia Patient will be positioned supine with the head slightly extended. . Sub-mental view, using C-arm image intensifier will be obtained to visualize foramen ovale just medial to mandibular arch. Skin entry site will be marked, which will be 2-2.5 cm lateral and 0.5 cm cephlad to angle of mouth. Needle will be inserted at the entry point and advanced parallel to C-arm in a co-axial manner to reach the entry of foramen ovale. Needle direction and depth will be checked fluoroscopically in the lateral view. The tip of the needle should be in line with the point where clivus joins the petrous part of temporal bone just below the entry of foramen ovale. Needle is aspirated for blood and CSF A 4F Fogarty catheter will be inserted 1.4 to 1.7 cm approximately beyond the tip of the needle so as to lie in the Meckel’s cave. Using a C-arm image intensifier in both anteroposterior and lateral views will identify position of the catheter’s tip. Catheter will be inflated slowly with 0.7 to 1.0 ml of radio-opaque contrast material and inflation of balloon will be observed in continuous C-arm in lateral view. Appearance of pear shaped balloon indicates that it is beginning to protrude out of the Meckel’s cave towards posterior fossa and a good squeeze can be achieved. The balloon will be kept inflated for 120 seconds. The needle with balloon is withdrawn as an unit under fluoroscopy 
Comparator Agent  Percutaneous Radiofrequency Thermocoagulation(PRT)   The procedure will be performed as a day care surgery under conscious sedation. Patient will be positioned supine with the head slightly extended. Skin of the face and anterior neck will be prepared with topical antiseptic solution and draped with sterile towels. Skin entry site will be marked, which will be 2-3 cm lateral and 0.5 cm cephlad to angle of mouth. 2% lidocaine is infiltrated for local anaesthesia. The foramen ovale will be entered with a 22 G RF needle. Fluoroscopic imaging will be performed for confirmation of the needle position. The RF needle will be inserted and sensory stimulation will be performed to verify correct location of electrode in desired segmental division of ganglion. Position and depth of the RF needle will be adjusted and positioned according to the stimulation effect. After confirmation, thermocoagulation will be performed for sixty seconds at 60° for the first lesion, subsequent thermocoagulation will be performed for sixty seconds at 70°. Between each thermocoagulation affected area will be tested for the pain and touch sensation by cold cotton swab and pin- prick. Similarly, corneal reflex will be tested after each radiofrequency thermocoagulation. Radiofrequency needle will be removed and the puncture site will be compressed with sterile swab for five minutes and a sterile dressing will be applied.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Thirty adult patients of either sex diagnosed to have Classical trigeminal neuralgia will be recruited for this study.

Classic TN will be diagnosed according to the International Classification of Headache Disorders-II (2004)

Classical TN of more than six months’ duration

Pain rating (during the attack) of at least six on a Visual analogue scale (VAS/NRS)

No satisfactory pain relief with medical treatment for more than three months; and/or intolerable side effects using oral medications
 
 
ExclusionCriteria 
Details  1. Patient’s refusal to involve in the study


2. History of allergy to drugs used in the procedures


3. Coagulopathy


4. Morbid obesity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Multi-dimensional outcomes as recommended by IMMPACT (Initiative on methods, measurement, and pain assessment in clinical trials)

The following domains were assessed

Pain: by 11point (0-10) NRS

Physical functioning: by Brief Pain Inventory-Facial scale

Emotional functioning: by Beck Depression Inventory

Global improvement: by Patient Global Impression of change
 		 Immediate post operative period

Day 7

Then every month till 1 year
 
 
Secondary Outcome  
Outcome  TimePoints 
Health related quality of life would be measured by EQ-5D-3L (paper version) questionnaire

Spontaneous reporting of symptoms and adverse events with open ended prompts with each visit

Complications to be noted:
Residual Pain
Dysaesthesia
Decreased corneal sensation
Masseter weakness
Diplopia and
Procedure related complications:  		 Immediate post op

at day 7

then

every month for 1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/02/2018 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The references are enumerated 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

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27.        Urculo E, Alfaro R, Arrazola M, Astudillo E, Rejas G . Trochlear nerve palsy after repeated percutaneous balloon compression for recurrent trigeminal neuralgia : Case report and pathologenic considerations. Neurosurgery. 2004; 54: 505-509.

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30.        Burton M. Onoforio. Radiofrequency percutaneous Gasserian ganglion lesions. Results in 140 patients with trigeminal pain. J. Neurosurg. 1975;42:132-39.

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