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IRCT20191003044963N1 IRCT 2020-06-01 Iran University of Medical Sciences Comparison of supra-laryngeal nerve block by sonography guided rout and conventional rout Comparison of supra-laryngeal nerve block by sonography guided rout and conventional rout for direct laryngoscopy surgeries in supraglottic mass biopsy 2020-06-09 anticipated 48 Complete https://irct.ir/trial/47161 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Supraglottic mass. Intervention 1: 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. Intervention 2: Control group: The laryngoscope is inserted through the mouth and driven into the larynx through the tongue so that the vocal cords are visible. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After completing the work and consulting with all the writers and executive agents, I will be decided.
public Salomeh Sehat Kashani
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2190 Sehat.s@iums.ac.ir Iran University of Medical Sciences scientific Salomeh Sehat Kashani
Hazrate Rasool hospital, Niyayesh street, Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2190 Sehat.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both Coagulation disorders History of seizures Disorders of consciousness and delirium Hypersensitivity to lidocaine Inability to move the neck Patients over 70 years J04.3 Supraglottitis, unspecified Treatment - Surgery Treatment - Surgery 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. Control group: The laryngoscope is inserted through the mouth and driven into the larynx through the tongue so that the vocal cords are visible. Patient's Satisfaction. Timepoint: End of surgery. Method of measurement: From 1 to 5 (based on Likert scale) by questionnaire. Surgeon's satisfaction. Timepoint: End of surgery. Method of measurement: From 1 to 5 (based on Likert scale) by questionnaire. Block's Hematoma. Timepoint: End of surgery. Method of measurement: Based on patient records. Iran University of Medical Sciences Approved 2020-02-04 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)