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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Flurbiprofen exate on a drip | Placebo Comparator | 30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flurbiprofen axidate combined with noise-cancelling headphones music | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The first day before surgery, the first day after surgery, and the second day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fujian | Fuzhou | 350000 | China |
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| Flurbiprofen axidate combined with noise-cancelling headphones | Behavioral | 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. |
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| Flurbiprofen exate on a drip | Other | 30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min. |
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| 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 | 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 | Within two days of surgery |
| Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents. | Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents. | 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 | Within two days of surgery |
| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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