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

NCT05825872 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2/2023ANET15-1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Sore Throat

Outcome Measures

Primary Outcomes (1)

• the pain classification of postoperative sore throat

  an established scoring system feom 0 to 4

  from immediate postoperative till 24 hours postoperative

Study Arms (2)

control group

NO INTERVENTION

patients will undergo a thoracoscopic surgery under general anesthesia with double-lumen bronchial intubation without any special treatment.

experimental group

ACTIVE COMPARATOR

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; Drug: Lidocaine 2% Injectable Solution; Drug: Bupivacaine 0.5% Injectable Solution

Interventions

internal superior laryngeal nerve block PROCEDURE

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

experimental group

Lidocaine 2% Injectable Solution DRUG

0.5 ml will be injected

experimental group

Bupivacaine 0.5% Injectable Solution DRUG

1.5 ml will be injected

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 to 3

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, 32513, Egypt

RECRUITING

MeSH Terms

Interventions

Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• mostafa s mansour

  Menoufia University

  STUDY CHAIR

Central Study Contacts

mostafa S mansour, MD

CONTACT

00201225484055; mostafa.said@med.menofia.edu.eg

islam M el-desoky, MD

CONTACT

00201092447887

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: April 5, 2023
• Primary Completion: July 5, 2023
• Study Completion: September 5, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)