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

NCT06790914 | Recruiting

• 1 other identifier: 2024KY115
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracoscopic Surgery; Hyperalgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Numerical Rating Scale（NRS）

  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

  Within one day 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.

  Within one day of surgery

• The number of adverse reactions (nausea, vomiting, hypotension, etc.) within 48 hours after surgery

  Within two days of surgery

Study Arms (3)

Flurbiprofen axidate combined with noise-cancelling headphones music

EXPERIMENTAL

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

flurbiprofen axidate combined with noise-cancelling earphone

EXPERIMENTAL

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

Flurbiprofen exate on a drip

PLACEBO COMPARATOR

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

Other: Flurbiprofen exate on a drip

Interventions

Flurbiprofen axidate combined with noise-cancelling headphones music 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 headphones music

Flurbiprofen axidate combined with noise-cancelling headphones 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 axidate combined with noise-cancelling earphone

Flurbiprofen exate on a drip OTHER

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

Flurbiprofen exate on a drip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fujian, Fuzhou, 350000, China

RECRUITING

MeSH Terms

Conditions

Hyperalgesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: January 24, 2025
• Study Start: March 17, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: January 24, 2025

Record last verified: 2024-07

Locations

CN (1)