Clinical trial NCT06790914: Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention
Official title: Investigation on the Status Quo of Hyperalgesia in Patients After Thoracoscopic Operation and Study on the Effect of Intraoperative Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracoscopic Surgery
Hyperalgesia
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The mechanical pain threshold of the medial forearm of the healthy side and the incision area
timeFrame: The first day before surgery, the first day after surgery, and the second day after surgery
Secondary outcomes:
measure: Numerical Rating Scale（NRS）
timeFrame: The first day before surgery, the first day after surgery, and the second day after surgery
measure: The first time additional analgesics (NRS≥4) are required after surgery
timeFrame: Within one day of surgery
measure: The effective number of PCA pump compressions within 48 h after surgery
timeFrame: Within two days of surgery
measure: Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.
timeFrame: Within one day of surgery
measure: The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery
timeFrame: Within two days of surgery
Other outcomes:
Locations:
city: Fujian
country: China
facility: Fujian Medical University Union Hospital
state: Fuzhou
Study officials:
References: