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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05825872
Other study ID # 2/2023ANET15-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 5, 2023
Est. completion date September 5, 2023

Study information

Verified date April 2023
Source Menoufia University
Contact mostafa S mansour, MD
Phone 00201225484055
Email mostafa.said@med.menofia.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date September 5, 2023
Est. primary completion date July 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Bupivacaine 0.5% Injectable Solution
1.5 ml will be injected

Locations

Country Name City State
Egypt Menoufia University Hospitals Shibin Al Kawm Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary the pain classification of postoperative sore throat an established scoring system feom 0 to 4 from immediate postoperative till 24 hours postoperative
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