Post Operative Sore ThroatFLURBI-POSTNCT07163429
Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation
A study testing Flurbiprofen 8.75 MG and Saline spray in people with Post Operative Sore Throat and Hoarseness, run by Kittitorn Supphapipat, MD at 1 site in Thailand.
Trial summary
The goal of this study is to evaluate whether topical flurbiprofen reduces the incidence and severity of postoperative sore throat (POST) and hoarseness in patients undergoing double-lumen tube (DLT) intubation for elective thoracic surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post Operative Sore Throat, Hoarseness
- What is being tested?
- Flurbiprofen 8.75 MG and Saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteThailand
- Study dates
- 10 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 20-80 years
- Undergoing elective thoracic surgery
- Requiring DLT intubation for lung separation
- ASA physical status classification I-III
- Able to communicate and understand the study
Who cannot join
- Contraindications to use of flurbiprofen, including allergies to flurbiprofen or NSAIDs, active peptic ulcer/ hemorrhage, history of gastrointestinal bleeding or perforation, severe colitis, severe heart failure, chronic kidney disease (CKD) stage IV or end-stage kidney disease (ESRD), or liver failure
- Recent or recurrent upper respiratory tract infection
- History of sore throat or hoarseness within 1 month prior to surgery
- History of previous airway surgery
- Chronic pain conditions
- Pregnancy
Show all 9Show fewer
- Withdrawal criteria
- Fail DLT intubation
- Inability to extubation at the end of surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, Mueang, 50200
About this study
Official title: Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation: A Randomized, Double-blind, Controlled Trial
The goal of this study is to evaluate whether topical flurbiprofen reduces the incidence and severity of postoperative sore throat (POST) and hoarseness in patients undergoing double-lumen tube (DLT) intubation for elective thoracic surgery.
The main question is: Does topical flurbiprofen reduce POST and hoarseness compared with placebo in patients undergoing DLT intubation? Researchers will compare topical flurbiprofen spray with placebo spray.
Participants will:
- Receive a DLT sprayed with either topical flurbiprofen or placebo before intubation.
- Be assessed for POST and hoarseness at 15 minutes, 2 hours, 12 hours, 24 hours, and 48 hours after surgery.
Read the detailed description
Postoperative sore throat (POST) is a common complication after general anesthesia involving airway manipulation, with reported incidence rates of up to 62%. It includes a spectrum of symptoms such as throat pain, pharyngitis, laryngitis, tracheitis, cough, hoarseness, and dysphagia, typically occurring in the early postoperative period. Although generally self-limiting, severe cases may cause dyspnea and dysphagia, reduce patient satisfaction, and in some cases prolong hospital stay.
POST results from laryngeal and tracheal mucosal injury during tracheal intubation. The pathophysiology is multifactorial, involving direct airway trauma, mucosal irritation and inflammation, ischemia from cuff compression, regurgitation of gastric contents, and gastric tube placement. Risk factors include female sex, younger age, smoking, lung disease, prolonged surgery, patient repositioning, difficult intubation, larger tube diameter, stylet use, high cuff pressure, and frequent suctioning.
The use of double-lumen tubes (DLTs), required for thoracic surgery with one-lung ventilation, has been associated with an even higher incidence of POST due to larger tube size, stylet-assisted insertion, and increased glottic trauma.
Several strategies have been investigated to prevent POST, including cuff pressure control, local anaesthetics, corticosteroids, and nonsteroidal anti-inflammatory drugs (NSAIDs). Dexamethasone and lidocaine have shown some benefit, but results are inconsistent, and POST remains prevalent in clinical practice.
Flurbiprofen, a nonsteroidal anti-inflammatory drug, is available as an oromucosal spray (8.75 mg/dose) and is widely used for sore throat relief in general practice. It reduces airway inflammation and provides analgesia when applied locally. Previous studies suggest that flurbiprofen spray applied to the cuff of laryngeal mask airways or single-lumen tubes reduces POST severity. However, limited evidence is available in the setting of DLT intubation, which carries a higher risk of POST.
This randomized, double-blind, placebo-controlled trial will investigate whether topical flurbiprofen spray applied to the cuff of a DLT before intubation reduces the incidence and severity of POST and hoarseness in patients undergoing elective thoracic surgery. Participants will be randomized to receive either topical flurbiprofen spray or placebo, with outcomes assessed at multiple time points up to 48 hours postoperatively. The study will be conducted at a single academic center, with standardized anesthesia management and blinding of patients, clinicians, and outcome assessors.
- Conditions
- Post Operative Sore Throat, Hoarseness
- Being tested
- Flurbiprofen 8.75 MG, Saline spray
- Keywords
- Postoperative sore throat (POST), Double-lumen intubation, Thoracic surgery, Flurbiprofen spray, Airway complications
- Medical subject headings
- Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurbiprofen 8.75 MGDrug
Also called Flurbiprofen spray
Topical administration of flurbiprofen 8.75 mg spray applied directly to the tracheal and bronchial cuffs of the double-lumen endobronchial tube before intubation. A total of three sprays will be applied: one spray to the bronchial cuff and two sprays to the tracheal cuff, immediately before intubation.
Saline sprayDrug
Topical administration of placebo spray (0.9% normal saline) applied in the same manner as the active intervention, with one spray to the bronchial cuff and two sprays to the tracheal cuff of the double-lumen tube before intubation.
| Study group | Role | What they receive |
|---|---|---|
| Flurbiprofen group | Experimental | Participants will receive topical flurbiprofen spray (one spray on the bronchial cuff and two spray on the tracheal cuff, with a total dose of 8.75 mg of flurbiprofen) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation Receives: Drug: Flurbiprofen 8.75 MG |
| Control group | Placebo comparator | Participants will receive placebo spray (0.9% normal saline) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation. Receives: Drug: Saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POST
Presence or absence of postoperative sore throat (POST)
Measured: Within 48 hours postoperatively
Secondary outcomes (4)
Severity of POST
Severity of sore throat measured using a numerical rating scale (0-10) and throat pain scale (TPS: 0 = none, 1 = mild, 2 = moderate, 3 = severe).
Measured: 15 minutes, 2, 12, 24, and 48 hours postoperatively
Incidence of hoarseness
Presence or absence of hoarseness
Measured: Within 48 hours postoperatively
Severity of hoarseness
Severity of hoarseness measured using a 4-point scale (HOAR: 0 = none, 1 = minimal, 2 = moderate, 3 = severe)
Measured: 15 minutes, 2, 12, 24, and 48 hours postoperatively
Patient satisfaction
Overall patient satisfaction intubation, measured using a 10-point satisfaction scale (0 = not satisfied, 10 = very satisfied)
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start10 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative Sore ThroatStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either topical flurbiprofen spray or placebo spray applied to the double-lumen tube cuffs before intubation. Outcomes will be assessed at multiple postoperative time points.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kittitorn Supphapipat, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kittitorn Supphapipat, MD, Chiang Mai University
- Investigators
- Kittitorn Supphapipat, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163429
- Sponsor's protocol ID
- ANE-2568-0331
- Acronym
- FLURBI-POST
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will not be shared because this is a single-centre investigator-initiated study with a limited sample size, and the data contain potentially sensitive patient information. De-identified summary data may be made available upon reasonable request to the principal investigator
Publications
Uzture N, Menda F, Bilgen S, Keskin O, Temur S, Koner O. The Effect of Flurbiprofen on Postoperative Sore Throat and Hoarseness After LMA-ProSeal Insertion: A Randomised, Clinical Trial. Turk J Anaesthesiol Reanim. 2014 Jun;42(3):123-7. doi: 10.5152/TJAR.2014.35693. Epub 2014 Mar 11.
PubMed 27366405Mazzotta E, Soghomonyan S, Hu LQ. Postoperative sore throat: prophylaxis and treatment. Front Pharmacol. 2023 Nov 23;14:1284071. doi: 10.3389/fphar.2023.1284071. eCollection 2023.
PubMed 38074131
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flurbiprofen Spray for Postoperative Sore Throat Following Double-Lumen Endobronchial Intubation: A Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07163429
- Acronym / sponsor ID
- FLURBI-POST / ANE-2568-0331
- Conditions
- Post Operative Sore Throat, Hoarseness
- Keywords
- Postoperative sore throat (POST), Double-lumen intubation, Thoracic surgery, Flurbiprofen spray, Airway complications
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Kittitorn Supphapipat, MDUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Sep 2025 (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.
The goal of this study is to evaluate whether topical flurbiprofen reduces the incidence and severity of postoperative sore throat (POST) and hoarseness in patients undergoing double-lumen tube (DLT) intubation for elective thoracic surgery.
The main question is: Does topical flurbiprofen reduce POST and hoarseness compared with placebo in patients undergoing DLT intubation? Researchers will compare topical flurbiprofen spray with placebo spray.
Participants will:
- Receive a DLT sprayed with either topical flurbiprofen or placebo before intubation.
- Be assessed for POST and hoarseness at 15 minutes, 2 hours, 12 hours, 24 hours, and 48 hours after surgery.
Detailed description
Postoperative sore throat (POST) is a common complication after general anesthesia involving airway manipulation, with reported incidence rates of up to 62%. It includes a spectrum of symptoms such as throat pain, pharyngitis, laryngitis, tracheitis, cough, hoarseness, and dysphagia, typically occurring in the early postoperative period. Although generally self-limiting, severe cases may cause dyspnea and dysphagia, reduce patient satisfaction, and in some cases prolong hospital stay.
POST results from laryngeal and tracheal mucosal injury during tracheal intubation. The pathophysiology is multifactorial, involving direct airway trauma, mucosal irritation and inflammation, ischemia from cuff compression, regurgitation of gastric contents, and gastric tube placement. Risk factors include female sex, younger age, smoking, lung disease, prolonged surgery, patient repositioning, difficult intubation, larger tube diameter, stylet use, high cuff pressure, and frequent suctioning.
The use of double-lumen tubes (DLTs), required for thoracic surgery with one-lung ventilation, has been associated with an even higher incidence of POST due to larger tube size, stylet-assisted insertion, and increased glottic trauma.
Several strategies have been investigated to prevent POST, including cuff pressure control, local anaesthetics, corticosteroids, and nonsteroidal anti-inflammatory drugs (NSAIDs). Dexamethasone and lidocaine have shown some benefit, but results are inconsistent, and POST remains prevalent in clinical practice.
Flurbiprofen, a nonsteroidal anti-inflammatory drug, is available as an oromucosal spray (8.75 mg/dose) and is widely used for sore throat relief in general practice. It reduces airway inflammation and provides analgesia when applied locally. Previous studies suggest that flurbiprofen spray applied to the cuff of laryngeal mask airways or single-lumen tubes reduces POST severity. However, limited evidence is available in the setting of DLT intubation, which carries a higher risk of POST.
This randomized, double-blind, placebo-controlled trial will investigate whether topical flurbiprofen spray applied to the cuff of a DLT before intubation reduces the incidence and severity of POST and hoarseness in patients undergoing elective thoracic surgery. Participants will be randomized to receive either topical flurbiprofen spray or placebo, with outcomes assessed at multiple time points up to 48 hours postoperatively. The study will be conducted at a single academic center, with standardized anesthesia management and blinding of patients, clinicians, and outcome assessors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either topical flurbiprofen spray or placebo spray applied to the double-lumen tube cuffs before intubation. Outcomes will be assessed at multiple postoperative time points.
| Arm | Type | Receives |
|---|---|---|
| Flurbiprofen group | Experimental | Drug: Flurbiprofen 8.75 MGParticipants will receive topical flurbiprofen spray (one spray on the bronchial cuff and two spray on the tracheal cuff, with a total dose of 8.75 mg of flurbiprofen) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation |
| Control group | Placebo comparator | Drug: Saline sprayParticipants will receive placebo spray (0.9% normal saline) applied to both the tracheal and bronchial cuffs of the double-lumen tube before intubation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 20-80 years
- Undergoing elective thoracic surgery
- Requiring DLT intubation for lung separation
- ASA physical status classification I-III
- Able to communicate and understand the study
Key exclusion criteria (9 listed)
- Contraindications to use of flurbiprofen, including allergies to flurbiprofen or NSAIDs, active peptic ulcer/ hemorrhage, history of gastrointestinal bleeding or perforation, severe colitis, severe heart failure, chronic kidney disease (CKD) stage IV or end-stage kidney disease (ESRD), or liver failure
- Recent or recurrent upper respiratory tract infection
- History of sore throat or hoarseness within 1 month prior to surgery
- History of previous airway surgery
- Chronic pain conditions
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 |
|---|---|---|
| Flurbiprofen 8.75 MGAlso: Flurbiprofen sprayTopical administration of flurbiprofen 8.75 mg spray applied directly to the tracheal and bronchial cuffs of the double-lumen endobronchial tube before intubation. A total of three sprays will be applied: one spray to the bronchial cuff and two sprays to the tracheal cuff, immediately before intubation. | Drug | Flurbiprofen group |
| Saline sprayTopical administration of placebo spray (0.9% normal saline) applied in the same manner as the active intervention, with one spray to the bronchial cuff and two sprays to the tracheal cuff of the double-lumen tube before intubation. | Drug | Control group |
Primary outcome
Incidence of POST
Time frame: Within 48 hours postoperatively
Presence or absence of postoperative sore throat (POST)
4 secondary outcomes
Severity of POST
Time frame: 15 minutes, 2, 12, 24, and 48 hours postoperatively
Incidence of hoarseness
Time frame: Within 48 hours postoperatively
Severity of hoarseness
Time frame: 15 minutes, 2, 12, 24, and 48 hours postoperatively
Patient satisfaction
Time frame: 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 27366405Uzture N, Menda F, Bilgen S, Keskin O, Temur S, Koner O. The Effect of Flurbiprofen on Postoperative Sore Throat and Hoarseness After LMA-ProSeal Insertion: A Randomised, Clinical Trial. Turk J Anaesthesiol Reanim. 2014 Jun;42(3):123-7. doi: 10.5152/TJAR.2014.35693. Epub 2014 Mar 11.
- Background: PubMed 38074131Mazzotta E, Soghomonyan S, Hu LQ. Postoperative sore throat: prophylaxis and treatment. Front Pharmacol. 2023 Nov 23;14:1284071. doi: 10.3389/fphar.2023.1284071. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data will not be shared because this is a single-centre investigator-initiated study with a limited sample size, and the data contain potentially sensitive patient information. De-identified summary data may be made available upon reasonable request to the principal investigator
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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.
Kittitorn Supphapipat, MD principal investigator
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flurbiprofen 8.75 MG and Saline spray in people with Post Operative Sore Throat and Hoarseness, run by Kittitorn Supphapipat, MD at 1 site in Thailand.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POST (time frame: Within 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163429, which also lists 2 linked publications.
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 Mar 2026.