Hyperalgesia, Thoracoscopic Surgery
Conditions
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.
Interventions
BEHAVIORALFlurbiprofen 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.
BEHAVIORALFlurbiprofen 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.
OTHERFlurbiprofen exate on a drip
30min before induction of general anesthesia, flurbiprofen axidate 50mg+ normal saline at 60 drops /min.
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed