Determining and comparing the effectiveness of two methods of peripheral Trigeminal nerve block with Gasserian ganglion block in patients with Trigeminal neuralgia
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 32 patients
Settings and conduct
In this randomized double-blind clinical trial, 32 eligible patients referred to Kashani and Al-Zahra hospitals in Isfahan will be included in the study and randomly divided into two groups. The first group will be under the trigeminal nerve block and the second group will be under the Gasserian ganglion block. Then the severity of pain and the location of pain will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age 18-65 years, having unilateral trigeminal neuralgia in the second, third, or both branches (approved by a neurologist), lack of proper response to medication, lack of coagulation disorders, lack of anatomical changes that It is not possible to do the block, no pregnancy and consent to enter the study. Exclusion criteria include Unsuccessful performance of blocks based on fluoroscopic criteria and having atypical pain.
Intervention groups
First intervention group: For the Trigeminal nerve block, after finding the pterygoid plate under fluoroscopic guide, 80 mg of triamcinolone and 100 mg of lidocaine in a volume of 10 ml are used.
The second intervention group: For the Gasserian ganglion block, after passing the needle through the foramen oval under fluoroscopic guide, 10 mg lidocaine and 30 mg triamcinolone are used.
Main outcome variables
Pain score; Location of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N42
Registration date:2021-10-02, 1400/07/10
Registration timing:prospective
Last update:2021-10-02, 1400/07/10
Update count:0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-22, 1401/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effectiveness of Trigeminal nerve block and Gasserian ganglion block in patients with Trigeminal nerve neuralgia
Public title
The effectiveness of Trigeminal nerve block and Gasserian ganglion block in patients with Trigeminal nerve neuralgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years
Having unilateral trigeminal neuralgia in the second, third or both branches (approved by a neurologist)
Lack of proper response to medication
Absence of coagulation disorders
Absence of anatomical changes that do not allow the block to be performed
No pregnancy
Satisfaction to enter the study
Exclusion criteria:
Unsuccessful performance of blocks based on fluoroscopic criteria
Having atypical pain
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 32 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly divided into two groups A (first intervention) and B (second intervention). Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
To meet the blinding condition in the study, the anesthesiologist that was responsible for performing intubation did not take part in the collection of patients’ information due to knowledge of the type of intervention in each of the two groups; however, the patient, the patient data collector, and the statistician were not aware of the type of intervention in two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-01-17, 1399/10/28
Ethics committee reference number
IR.MUI.MED.REC.1399.955
Health conditions studied
1
Description of health condition studied
Trigeminal neuralgia
ICD-10 code
G50.0
ICD-10 code description
Trigeminal neuralgia
Primary outcomes
1
Description
Pain score
Timepoint
One hour, one week, two weeks, three weeks and four weeks after the intervention
Method of measurement
Visual Analog Scale (VAS)
2
Description
The place of pain
Timepoint
One hour, one week, two weeks, three weeks and four weeks after the intervention
Method of measurement
Observation (Reported by the patient)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: For the Trigeminal nerve block, after finding the pterygoid plate under fluoroscopic guide, 80 mg of triamcinolone and 100 mg of lidocaine in a volume of 10 ml are used.
Category
Treatment - Other
2
Description
The second intervention group: For the Gasserian ganglion block, after passing the needle through the foramen oval under fluoroscopic guide, 10 mg lidocaine and 30 mg triamcinolone are used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mehran Rezvani Habibabadi
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street