Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Medical University Union Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Flurbiprofen exate on a drip

    Other intervention

    30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Flurbiprofen axidate combined with noise-cancelling headphones musicExperimental treatment 1 intervention
Group B: flurbiprofen axidate combined with noise-cancelling earphoneExperimental treatment 1 intervention
Group C: Flurbiprofen exate on a dripPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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