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
|
|
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
|
|
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. |