An interventional study of Flurbiprofen axidate combined with noise-cancelling headphones music and Flurbiprofen axidate combined with noise-cancelling headphones in Thoracoscopic Surgery and Hyperalgesia, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Fujian Medical University Union Hospital · Not applicable, Interventional, and Supportive care
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.
166 studies on the registry are indexed under Hyperalgesia; 14 are open to participants now.
This study's planned enrollment of 90 is above the median of 50 across 142 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Fujian Medical University Union Hospital is the lead sponsor of 109 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones music
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.
Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones
30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min.
Other: Flurbiprofen exate on a drip
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.
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.
30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min.
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.
Time frame: The first day before surgery, the first day after surgery, and the second day after surgery
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.
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
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
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.
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
The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery
Time frame: Within two days of surgery
Started Mar 2024 (actual). Primary completion is estimated for Mar 2025, 12 months after the start.
Of 27 non-industry interventional studies with no phase under Hyperalgesia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's planned 12 months is close to that.
Counting every sponsor, half of 27 studies reached it within 11 months; a quarter within 4 and three quarters within 32.
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