Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube

Effect of Ultrasound-Guided Internal Superior Laryngeal Nerve Block on Sore Throat After Intubation by Double-Lumen Bronchial Tube for Thoracoscopic Surgery

investigate the effectiveness and safety of ultrasound-guided bilateral internal branch of the SLN (iSLN) block for alleviating POST immediately after the operation.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Sore Throat
• Intervention / Treatment: Procedure: internal superior laryngeal nerve block; Drug: Lidocaine 2% Injectable Solution; Drug: Bupivacaine 0.5% Injectable Solution

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: mostafa S mansour, MD; Phone Number: 00201225484055; Email: mostafa.said@med.menofia.edu.eg
• Study Contact Backup: Name: islam M el-desoky, MD; Phone Number: 00201092447887

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32513
      • Recruiting
      • Menoufia University Hospitals
      • Principal Investigator: islam el-desoky, MD
      • Contact: Ghada Ali, MD; Phone Number: 01001775783; Email: ghadaali132@yahoo.com
      • Principal Investigator: ahmed helwa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA 1 to 3

Exclusion Criteria:

• patients who did not provide consent
• with a pre-existing sore throat, hoarseness and upper respiratory tract infection
• tracheal pathology, tracheostomy
• a history of psychosis, diabetes and thyroid, oral cavity or pharynx surgery
• known or suspected allergy to ropivacaine
• chronic opioid use
• use of nonsteroidal anti-inflammatory drug medication within 24 hours
• known or suspected difficult airway
• patients who will be supported by tube ventilator after the operation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; patients will undergo a thoracoscopic surgery under general anesthesia with double-lumen bronchial intubation without any special treatment.
Active Comparator: experimental group; patients will receive US-guided iSLN block bilaterally with 2 ml of ( 0.5 ml of 2%lidocaine and 1,5 ml of 0.5% bupivacaine) on either side immediate after the operation concomitant with GA in order to undergo thoracoscopic surgery	Procedure: internal superior laryngeal nerve block; A linear 4- to 12-MHz ultrasound probe will be placed in the oblique parasagittal plane to obtain an image of the hyoid bone and the thyroid cartilage. The probe will be kept parasagitally, and the following structures will be identified anteriorly to posteriorly: omohyoid muscle, sternohyoid muscle, thyrohyoid muscle, thyrohyoid membrane, superior laryngeal artery, and pre-epiglottis space. After identifying the local anatomic structure, a needle will be inserted out-plane from anterior to posterior. The muscles above the thyrohyoid membrane will be penetrated and hydrodissected; local anesthetic will be injected into the superior laryngeal nerve space. The superior laryngeal nerve space will be located between the hyoid bone (cephalad) and the thyroid cartilage (caudal) and delimited between the thyrohyoid muscle, anteriorly, and the thyrohyoid membrane and the pre-epiglottis space, posteriorly; Drug: Lidocaine 2% Injectable Solution; 0.5 ml will be injected; Drug: Bupivacaine 0.5% Injectable Solution; 1.5 ml will be injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the pain classification of postoperative sore throat	an established scoring system feom 0 to 4	from immediate postoperative till 24 hours postoperative

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: mostafa s mansour, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Anticipated): July 5, 2023
• Study Completion (Anticipated): September 5, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Pharmaceutical Solutions; Bupivacaine
• Other Study ID Numbers: 2/2023ANET15-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes