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

January 19, 2025 updated by: Fujian Medical University Union Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fuzhou
      • Fujian, Fuzhou, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The first day before surgery, the first day after surgery, and the second day after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Within one day of 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
Time Frame: Within two days of 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.
Time Frame: Within one day of surgery
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
Time Frame: Within two days of surgery
The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery
Within two days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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