Ultrasound Guided Superior Laryngeal Nerve Block Compared With Blind Block Technique

Ultrasound Guided Bilateral Superior Laryngeal Nerve Block Compared With Blind Block Technique For Awake Fibre-optic Intubation In Suspected Difficult Intubation

The aim of this study is to evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve in surgical patient in comparison to blind anatomical technique.

Study Overview

• Status: Unknown
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Device: ultrasound technique

Detailed Description

Airway anesthesia is pivotal for successful awake intubation provided either topically or by nerves blocks. Airway blocks are technically harder to perform with more complications possibilities. However, in experienced hands, they can be useful as they provide better intubating conditions.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alshaymaa Mortada Ali Eltohry, M.B.B.CH; Phone Number: +201006485550; Email: alshaymaaali62@gmail.com
• Study Contact Backup: Name: sanaa Mohamed El Fawal, professor; Phone Number: +201143504178; Email: sana_y_fawal@yahoo.com

Study Locations

• Egypt
  • Please Select An Option
    • Alexandria, Please Select An Option, Egypt, 21500
      • Recruiting
      • Alshaymaa Mortada Ali Eltohry
      • Contact: Alshaymaa Mortada A Eltohry; Phone Number: 01006485550; Email: alshaymaaali62@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American Society of Anesthesiologists ( ASA ) physical status I and II.
2. Age between 40-60 years.
3. Modified Mallampati class III-IV .

Exclusion Criteria:

1. Local pathology of the neck.
2. Bleeding diathesis.
3. Allergy to local anesthetic agent.
4. Intellectual impairment.
5. Psychiatric disease.
6. Body mass index ≥30 kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ultrasound group; patient using ultrasound technique.probe will be placed over submandibular area, the thyrohoid muscle and thyrohyoid membrane will be identified between greater horn fo hyoid bone and thyroid cartilage , 3 ml of lignocaine will be placed on space between thim and the procedure will repeated on contra lateral side.	Device: ultrasound technique; evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve
ACTIVE_COMPARATOR: anatomical blind group; patient using anatomical land mark technique, internal branch of superior laryngeal nerve will be blocked slightly anterior to greater horn of hyoid bone . by 3 ml lignocaine . the procdure will be repeated on contra lateral side .	Device: ultrasound technique; evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment the quality of airway anesthesia	The Quality of Airway anesthesia will be graded as: 0 = no coughing or gagging in response to intubation, 1 = mild coughing or gagging that will not hinder intubation, 2 = moderate coughing or gagging that will interfere minimally with intubation,3 = severe coughing or gagging that make intubation difficult and 4 = very severe coughing or gagging that will require additional local anesthetic or change in technique to achieve successful intubation.	Up to 2 years post baseline

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Azza Mohamed Shafik, professor, Ain Shams University, Faculty of Medicine; Study Director: Abeer Mohamed Abdel-Aziz, professor, Ain Shams University, Faculty of Medicine

Publications and helpful links

General Publications

• Manikandan S, Neema PK, Rathod RC. Ultrasound-guided bilateral superior laryngeal nerve block to aid awake endotracheal intubation in a patient with cervical spine disease for emergency surgery. Anaesth Intensive Care. 2010 Sep;38(5):946-8. doi: 10.1177/0310057X1003800523.
• Ramkumar V. Preparation of the patient and the airway for awake intubation. Indian J Anaesth. 2011 Sep;55(5):442-7. doi: 10.4103/0019-5049.89863.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (ACTUAL): November 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Suspected Difficult Intubation
• Other Study ID Numbers: FMASU MS 19/ 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No