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.

Study Overview

• Status: Recruiting
• Conditions: Hyperalgesia; Thoracoscopic Surgery
• Intervention / Treatment: Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones music; Behavioral: Flurbiprofen axidate combined with noise-cancelling headphones; Other: Flurbiprofen exate on a drip

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fuzhou
    • Fujian, Fuzhou, China, 350000
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Yanjuan Lin; Phone Number: +86 591 8621 8336; Email: fjxhyjl@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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 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.
Experimental: flurbiprofen axidate combined with noise-cancelling earphone; 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 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.
Placebo Comparator: Flurbiprofen exate on a drip; 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 at 60 drops /min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The first day before surgery, the first day after surgery, and the second day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	Within two days of surgery
Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.	Total intraoperative use of remifentanil, sevoflurane, and vasoactive agents.	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	Within two days of surgery

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2024
• Primary Completion (Estimated): March 17, 2025
• Study Completion (Estimated): March 17, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Somatosensory Disorders; Hyperalgesia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Flurbiprofen
• Other Study ID Numbers: 2024KY115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No