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NCT Number: NCT06790914

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

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.

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Key information

Conditions

Thoracoscopic Surgery Hyperalgesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Numerical Rating Scale（NRS）

    Time frame: The first day before surgery, the first day after surgery, and the second day after surgery

    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.

  2. The first time additional analgesics (NRS≥4) are required after surgery

    Time frame: Within one day of surgery

    The first time additional analgesics (NRS≥4) are required after surgery

  3. The effective number of PCA pump compressions within 48 h after surgery

    Time frame: Within two days of surgery

    The effective number of PCA pump compressions within 48 h after surgery

  4. Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.

    Time frame: Within one day of surgery

    Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.

  5. The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery

    Time frame: Within two days of surgery

    The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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