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

Primary Purpose

Postoperative Sore Throat

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
internal superior laryngeal nerve block
Lidocaine 2% Injectable Solution
Bupivacaine 0.5% Injectable Solution
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Sore Throat

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Menoufia University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

experimental group

Arm Description

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

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

Outcomes

Primary Outcome Measures

the pain classification of postoperative sore throat
an established scoring system feom 0 to 4

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
April 11, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05825872
Brief Title
Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube
Official Title
Effect of Ultrasound-Guided Internal Superior Laryngeal Nerve Block on Sore Throat After Intubation by Double-Lumen Bronchial Tube for Thoracoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
July 5, 2023 (Anticipated)
Study Completion Date
September 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
patients will undergo a thoracoscopic surgery under general anesthesia with double-lumen bronchial intubation without any special treatment.
Arm Title
experimental group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
internal superior laryngeal nerve block
Intervention Description
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
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Intervention Description
0.5 ml will be injected
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5% Injectable Solution
Intervention Description
1.5 ml will be injected
Primary Outcome Measure Information:
Title
the pain classification of postoperative sore throat
Description
an established scoring system feom 0 to 4
Time Frame
from immediate postoperative till 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa S mansour, MD
Phone
00201225484055
Email
mostafa.said@med.menofia.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
islam M el-desoky, MD
Phone
00201092447887
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mostafa s mansour
Organizational Affiliation
Menoufia University
Official's Role
Study Chair
Facility Information:
Facility Name
Menoufia University Hospitals
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32513
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghada Ali, MD
Phone
01001775783
Email
ghadaali132@yahoo.com
First Name & Middle Initial & Last Name & Degree
islam el-desoky, MD
First Name & Middle Initial & Last Name & Degree
ahmed helwa, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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