Thoracoscopic SurgeryNCT06790914
Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention
A study testing Flurbiprofen axidate combined with noise-cancelling headphones music, Flurbiprofen axidate combined with noise-cancelling headphones and Flurbiprofen exate on a drip in people with Thoracoscopic Surgery and Hyperalgesia, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
To explore the status quo and influencing factors of hyperpain in patients after thoracoscopic surgery, and to explore the effect of earphone sound isolation during combined operation of flurbiprofen axidate and binaural beat music played by earphone during combined operation on the intervention of hyperpain after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoscopic Surgery, Hyperalgesia
- What is being tested?
- Flurbiprofen axidate combined with noise-cancelling headphones music, Flurbiprofen axidate combined with noise-cancelling headphones and Flurbiprofen exate on a drip
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2024to 17 Mar 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients selected by the same group of surgeons to perform thoracoscopic three-hole radical resection of lung cancer
- Patients ≥18 years old, able to communicate effectively and cooperate with the completion of clinical trials
- ASA grade I-III
- Normal hearing; Patients who have not participated in other trials in the last two months
Who cannot join
- Previous history of thoracic surgery
- History of chronic pain and any intake of analgesics 48 hours before surgery; ● Have a history of mental illness, or have taken psychiatric drugs or received psychological treatment in the past six months
- Deformity of the auricle, inability to wear headphones, and failure to cooperate with this study for any reason
- suffering from concurrent severe organ system diseases and hearing impairment
- Incomplete data collection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fujian, Fuzhou, 350000
Yanjuan Lin, +86 591 8621 8336, fjxhyjl@163.com
About this study
To explore the status quo and influencing factors of hyperpain in patients after thoracoscopic surgery, and to explore the effect of earphone sound isolation during combined operation of flurbiprofen axidate and binaural beat music played by earphone during combined operation on the intervention of hyperpain after thoracoscopic surgery.
Read the detailed description
In this study, patients undergoing thoracoscopy radical lung cancer surgery in Union Hospital Affiliated to Fujian Medical University were selected for A randomized controlled trial. Patients were selected according to the inclusion and exclusion criteria, and the patients were randomly divided into group A of flurbiprofen axidate combined with noise-canceling headset music test, group B of flurbiprofen axidate combined with noise-canceling headset test, and the control group for intraoperative intervention study.
- Conditions
- Thoracoscopic Surgery, Hyperalgesia
- Being tested
- Flurbiprofen axidate combined with noise-cancelling headphones music, Flurbiprofen axidate combined with noise-cancelling headphones, Flurbiprofen exate on a drip
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurbiprofen axidate combined with noise-cancelling headphones musicBehavioural
30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After general anesthesia induction, noise-cancelling headphones (Sony WH-1000XM3) were fully covered with both ears, and MP3 (GoGear, Philips) was connected to play music continuously until the headphones were removed after the operation.
Flurbiprofen axidate combined with noise-cancelling headphonesBehavioural
30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After induction of general anesthesia, noise-cancelling headphones (Sony WH-1000XM3) were applied to cover both ears completely until the headphones were removed at the end of the procedure.
Flurbiprofen exate on a dripOther
30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min.
| Study group | Role | What they receive |
|---|---|---|
| Flurbiprofen axidate combined with noise-cancelling headphones music | Experimental | 30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After general anesthesia induction, noise-cancelling headphones (Sony WH-1000XM3) were fully covered with both ears, and MP3 (GoGear, Philips) was connected to play music continuously until the headphones were removed after the operation. Receives: Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones music |
| flurbiprofen axidate combined with noise-cancelling earphone | Experimental | 30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After induction of general anesthesia, noise-cancelling headphones (Sony WH-1000XM3) were applied to cover both ears completely until the headphones were removed at the end of the procedure. Receives: Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones |
| Flurbiprofen exate on a drip | Placebo comparator | 30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min. Receives: Other: Flurbiprofen exate on a drip |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mechanical pain threshold of the medial forearm of the healthy side and the incision area
Von Frey cilia were used to measure the pain threshold of the patients. There were 20 kinds of Von Frey cilia intensity, and the corresponding mechanical pain threshold ranges from 0.008 to 300g. Hyperalgesia occurs when values around the incision and/or in the non-dominant forearm are reduced after surgery compared to before surgery.
Measured: The first day before surgery, the first day after surgery, and the second day after surgery
Secondary outcomes (5)
Numerical Rating Scale（NRS）
NRS is a number from 0 to 10 used instead of words to indicate the severity of pain. Score 0 was no pain; 1 to 3 are classified as mild pain, tolerable, and sleep is not affected; 4 to 6 are classified as moderate pain, which begins to affect the patient's sleep and requires the use of painkillers; 7 ~ 9 is classified as severe pain, patients with unbearable pain, affect appetite, sleep is seriously disturbed, autonomic nerve is disturbed; 10 is severe pain.
Measured: The first day before surgery, the first day after surgery, and the second day after surgery
The first time additional analgesics (NRS≥4) are required after surgery
The first time additional analgesics (NRS≥4) are required after surgery
Measured: Within one day of surgery
The effective number of PCA pump compressions within 48 h after surgery
The effective number of PCA pump compressions within 48 h after surgery
Measured: Within two days of surgery
Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.
Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.
Measured: Within one day of surgery
The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery
The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery
Measured: Within two days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start17 Mar 2024
- Primary completion17 Mar 2025 (estimated)
- Study completion17 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790914
- Sponsor's protocol ID
- 2024KY115
- Status last verified
- Jul 2024
- First submitted
- 26 Nov 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention
- ClinicalTrials.gov ID
- NCT06790914
- Acronym / sponsor ID
- 2024KY115
- Conditions
- Thoracoscopic Surgery, Hyperalgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 17 Mar 2024 (actual)
- Primary completion
- 17 Mar 2025 (estimated)
- Study completion
- 17 Mar 2025 (estimated)
- First posted
- 24 Jan 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.
To explore the status quo and influencing factors of hyperpain in patients after thoracoscopic surgery, and to explore the effect of earphone sound isolation during combined operation of flurbiprofen axidate and binaural beat music played by earphone during combined operation on the intervention of hyperpain after thoracoscopic surgery.
Detailed description
In this study, patients undergoing thoracoscopy radical lung cancer surgery in Union Hospital Affiliated to Fujian Medical University were selected for A randomized controlled trial. Patients were selected according to the inclusion and exclusion criteria, and the patients were randomly divided into group A of flurbiprofen axidate combined with noise-canceling headset music test, group B of flurbiprofen axidate combined with noise-canceling headset test, and the control group for intraoperative intervention study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flurbiprofen axidate combined with noise-cancelling headphones music | Experimental | Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones music30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After general anesthesia induction, noise-cancelling headphones (Sony WH-1000XM3) were fully covered with both ears, and MP3 (GoGear, Philips) was connected to play music continuously until the headphones were removed after the operation. |
| flurbiprofen axidate combined with noise-cancelling earphone | Experimental | Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After induction of general anesthesia, noise-cancelling headphones (Sony WH-1000XM3) were applied to cover both ears completely until the headphones were removed at the end of the procedure. |
| Flurbiprofen exate on a drip | Placebo comparator | Other: Flurbiprofen exate on a drip30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients selected by the same group of surgeons to perform thoracoscopic three-hole radical resection of lung cancer
- Patients ≥18 years old, able to communicate effectively and cooperate with the completion of clinical trials
- ASA grade I-III
- Normal hearing; Patients who have not participated in other trials in the last two months
Key exclusion criteria (5 listed)
- Previous history of thoracic surgery
- History of chronic pain and any intake of analgesics 48 hours before surgery; ● Have a history of mental illness, or have taken psychiatric drugs or received psychological treatment in the past six months
- Deformity of the auricle, inability to wear headphones, and failure to cooperate with this study for any reason
- suffering from concurrent severe organ system diseases and hearing impairment
- Incomplete data collection
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 axidate combined with noise-cancelling headphones music30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After general anesthesia induction, noise-cancelling headphones (Sony WH-1000XM3) were fully covered with both ears, and MP3 (GoGear, Philips) was connected to play music continuously until the headphones were removed after the operation. | Behavioural | Flurbiprofen axidate combined with noise-cancelling headphones music |
| Flurbiprofen axidate combined with noise-cancelling headphones30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline 50ml at 60 drops /min; After induction of general anesthesia, noise-cancelling headphones (Sony WH-1000XM3) were applied to cover both ears completely until the headphones were removed at the end of the procedure. | Behavioural | flurbiprofen axidate combined with noise-cancelling earphone |
| Flurbiprofen exate on a drip30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min. | Other | Flurbiprofen exate on a drip |
Primary outcome
The mechanical pain threshold of the medial forearm of the healthy side and the incision area
Time frame: The first day before surgery, the first day after surgery, and the second day after surgery
Von Frey cilia were used to measure the pain threshold of the patients. There were 20 kinds of Von Frey cilia intensity, and the corresponding mechanical pain threshold ranges from 0.008 to 300g. Hyperalgesia occurs when values around the incision and/or in the non-dominant forearm are reduced after surgery compared to before surgery.
5 secondary outcomes
Numerical Rating Scale（NRS）
Time frame: The first day before surgery, the first day after surgery, and the second day after surgery
The first time additional analgesics (NRS≥4) are required after surgery
Time frame: Within one day of surgery
The effective number of PCA pump compressions within 48 h after surgery
Time frame: Within two days of surgery
Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.
Time frame: Within one day of surgery
The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery
Time frame: Within two days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
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 axidate combined with noise-cancelling headphones music, Flurbiprofen axidate combined with noise-cancelling headphones and Flurbiprofen exate on a drip in people with Thoracoscopic Surgery and Hyperalgesia, run by Fujian Medical University Union Hospital at 1 site in China.
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 4 inclusion and 5 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 Jan 2025. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mechanical pain threshold of the medial forearm of the healthy side and the incision area (time frame: The first day before surgery, the first day after surgery, and the second day after surgery). 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 Jan 2025.