Comparison of supra-laryngeal nerve block by sonography guided rout and conventional rout for direct laryngoscopy surgeries in supraglottic mass biopsy
Comparison of supra-laryngeal nerve block by sonography guided rout and conventional rout for direct laryngoscopy surgeries in supraglottic mass biopsy
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 48 patients. In order to randomize, the block randomization method will be used.
Settings and conduct
The study will be done on all patients referred to Hazrat Rasoul Hospital. The study will be double blind in which patients, therapists and data analysts will be blind. Patients will be unaware of which treatment will be offered in that group.
The therapist will not know which method will be used for each patient.
The analyst will also analyze the information based on groups 1 and 2 and will not know the type of treatment provided in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients referred to the of Hazrat Rasoul Akram Hospital, who needed direct laryngoscopy surgeries in supraglottic masses biopsy; Patients over 18 years; Patients with BMI below 30. Non-inclusion criteria: Coagulation disorders; History of seizures; Disorders of consciousness and delirium; Hypersensitivity to lidocaine; Inability to move the neck; Patients over 70 years.
Intervention groups
Intervention group: Supra-laryngeal nerve block by sonography: In the ultrasound technique, the probe is placed in the submandibular region, between the GHH bone and the thyroid cartilage above the hyoid space, 2 cc of lidocaine 2% is injected with gauge 23 needle.
Control group: The laryngoscope is inserted through the mouth and driven into the larynx through the tongue so that the vocal cords are visible.
Comparison of supra-laryngeal nerve block by sonography guided rout and conventional rout for direct laryngoscopy surgeries in supraglottic mass biopsy
Public title
Comparison of supra-laryngeal nerve block by sonography guided rout and conventional rout
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the of Hazrat Rasoul Akram Hospital, who needed direct laryngoscopy surgeries in supraglottic masses biopsy
Patients over 18 years old
BMI below 30
Exclusion criteria:
Coagulation disorders
History of seizures
Disorders of consciousness and delirium
Hypersensitivity to lidocaine
Inability to move the neck
Patients over 70 years
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 6. In each block, 3 individuals will be in intervention group and 3 will be in control group. A total of 8 blocks will be considered for the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data will be analyzed by person who is blind to study groups. The therapist and patients will also be unaware of the type of treatment.
Patients will be aware that they will be randomly assigned to one of two treatment groups, but will be unaware of which treatment will be provided in that group. Patients will be assigned to one of two groups using random number tables.
The therapist also knows that patients will be treated with two different methods of supra-laryngeal nerve block, but will not know which method will be performed for each patient.
The analyst will also analyze the information based on groups 1 and 2 and will not have the type of treatment offered in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.IUMS.FMD.REC.1398.490
Health conditions studied
1
Description of health condition studied
Supraglottic mass
ICD-10 code
J04.3
ICD-10 code description
Supraglottitis, unspecified
Primary outcomes
1
Description
Patient's Satisfaction
Timepoint
End of surgery
Method of measurement
From 1 to 5 (based on Likert scale) by questionnaire
2
Description
Surgeon's satisfaction
Timepoint
End of surgery
Method of measurement
From 1 to 5 (based on Likert scale) by questionnaire
3
Description
Block's Hematoma
Timepoint
End of surgery
Method of measurement
Based on patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the ultrasound technique, the probe is placed in the submandibular region and the GHH bone is diagnosed along with the thyroid cartilage. Between the GHH bone and the thyroid cartilage above the hyoid space, 2 cc of lidocaine 2% is injected with gauge 23 needle.
Category
Treatment - Surgery
2
Description
Control group: The laryngoscope is inserted through the mouth and driven into the larynx through the tongue so that the vocal cords are visible.