Postoperative Sore ThroatPhase 4NCT05825872
Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube
A Phase 4 study testing internal superior laryngeal nerve block, Lidocaine 2% Injectable Solution and Bupivacaine 0.5% Injectable Solution in people with Postoperative Sore Throat, run by Menoufia University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- internal superior laryngeal nerve block, Lidocaine 2% Injectable Solution and Bupivacaine 0.5% Injectable Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2023to 5 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 to 3
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
islam M el-desoky, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University Hospitals
Shibīn al Kawm, Menoufia, 32513
Ghada Ali, MD, 01001775783, ghadaali132@yahoo.com
islam el-desoky, MD
About this study
Official title: 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.
- Conditions
- Postoperative Sore Throat
- Being tested
- internal superior laryngeal nerve block, Lidocaine 2% Injectable Solution, Bupivacaine 0.5% Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal superior laryngeal nerve blockProcedure or surgery
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 SolutionDrug
0.5 ml will be injected
Bupivacaine 0.5% Injectable SolutionDrug
1.5 ml will be injected
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: internal superior laryngeal nerve block; Drug: Lidocaine 2% Injectable Solution; Drug: Bupivacaine 0.5% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pain classification of postoperative sore throat
an established scoring system feom 0 to 4
Measured: from immediate postoperative till 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start5 Apr 2023
- Primary completion5 Jul 2023 (estimated)
- Study completion5 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
- Investigators
- mostafa s mansour, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825872
- Sponsor's protocol ID
- 2/2023ANET15-1
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-Guided Internal Superior Laryngeal Nerve Block on Sore Throat After Intubation by Double-Lumen Bronchial Tube for Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05825872
- Acronym / sponsor ID
- 2/2023ANET15-1
- Conditions
- Postoperative Sore Throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Jul 2023 (estimated)
- Study completion
- 5 Sep 2023 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
investigate the effectiveness and safety of ultrasound-guided bilateral internal branch of the SLN (iSLN) block for alleviating POST immediately after the operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: internal superior laryngeal nerve block, Drug: Lidocaine 2% Injectable Solution, Drug: Bupivacaine 0.5% Injectable Solutionpatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 to 3
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internal superior laryngeal nerve blockA 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 | Procedure or surgery | experimental group |
| Lidocaine 2% Injectable Solution0.5 ml will be injected | Drug | experimental group |
| Bupivacaine 0.5% Injectable Solution1.5 ml will be injected | Drug | experimental group |
Primary outcome
the pain classification of postoperative sore throat
Time frame: from immediate postoperative till 24 hours postoperative
an established scoring system feom 0 to 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
islam M el-desoky, MD contact
mostafa s mansour study chair
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing internal superior laryngeal nerve block, Lidocaine 2% Injectable Solution and Bupivacaine 0.5% Injectable Solution in people with Postoperative Sore Throat, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa S mansour, MD (00201225484055, mostafa.said@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pain classification of postoperative sore throat (time frame: from immediate postoperative till 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.