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

NCT ID: NCT05825872

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2023-09-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

internal superior laryngeal nerve block

Intervention Type: 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

Lidocaine 2% Injectable Solution

Intervention Type: DRUG

0.5 ml will be injected

Bupivacaine 0.5% Injectable Solution

Intervention Type: DRUG

1.5 ml will be injected

Interventions

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

Intervention Type: PROCEDURE

Lidocaine 2% Injectable Solution

0.5 ml will be injected

Intervention Type: DRUG

Bupivacaine 0.5% Injectable Solution

1.5 ml will be injected

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

mostafa saieed fahim mansour

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mostafa s mansour

Role: STUDY_CHAIR

Menoufia University

Locations

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mostafa S mansour, MD

Role: CONTACT

mostafa.said@med.menofia.edu.eg

00201225484055

islam M el-desoky, MD

Role: CONTACT

00201092447887

Facility Contacts

Ghada Ali, MD

Role: primary

ghadaali132@yahoo.com

01001775783

Other Identifiers

2/2023ANET15-1

Identifier Type: -

Identifier Source: org_study_id