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

Not Applicable

Recruiting

• Conditions: Thoracoscopic Surgery; Hyperalgesia

• Registration Number: NCT06790914
• Lead Sponsor: Fujian Medical University Union Hospital

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.

Study Timeline

• Study Start: 2024-03-17
• Status Verified: 2024-07
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-03-17
• Study Completion: 2025-03-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The mechanical pain threshold of the medial forearm of the healthy side and the incision area	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 Outcome Measures

Name	Time	Method
Numerical Rating Scale（NRS）	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.
The first time additional analgesics (NRS≥4) are required after surgery	Within one day of surgery	The first time additional analgesics (NRS≥4) are required after surgery
The effective number of PCA pump compressions within 48 h after surgery	Within two days of surgery	The effective number of PCA pump compressions within 48 h after surgery
Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.	Within one day of surgery	Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.
The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery	Within two days of surgery	The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fujian, Fuzhou, China

Fujian Medical University Union Hospital

🇨🇳Fujian, Fuzhou, China