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

NCT ID: NCT06790914

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-17

Study Completion Date

2025-03-17

Brief Summary

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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

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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.

Conditions

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Thoracoscopic Surgery Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Flurbiprofen axidate combined with noise-cancelling headphones music

Intervention Type 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 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.

Group Type EXPERIMENTAL

Flurbiprofen axidate combined with noise-cancelling headphones

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Flurbiprofen exate on a drip

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Flurbiprofen exate on a drip

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University Union Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Medical University Union Hospital

Fujian, Fuzhou, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanjuan Lin

Role: primary

+86 591 8621 8336

Other Identifiers

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2024KY115

Identifier Type: -

Identifier Source: org_study_id

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