A randomized controlled, prospective, multicenter, open label, superiority trial aims to evaluate the effectiveness and safety of adjuvant software based on virtual reality for post-thoracoscopic surgery pain.
215 eligible patients will be enrolled. All enrolled patients will have an NRS score at 24 hours postoperatively, and those with a score greater than or equal to 4 will be randomly assigned to the test and control groups. Patients in the experimental group will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes. The control group will not experience postoperative analgesic adjuvant therapy software and will only record the pain level within 30 minutes. Subjects will complete a study summary form upon completion of follow-up. All participants will receive intravenous analgesics pumped with mechanical pumps (analgesic pumps: Flurbiprofen cilexil Injection 5ml: 50mg/stick\*4 sticks, combined with Dezocine Injection 1ml: 5mg/stick\*6 sticks, add Ondansetron Hydrochloride Injection: 2ml: 4mg/stick\*2 sticks; or add Tolisetron Mesylate Injection: 2ml: 6 mg/stick\*4 sticks, diluted to 100mL with 0.9% sodium chloride injection).In case of an outbreak of pain (when analgesic pump is ineffective and the pain is unbearable), analgesic medication regimen: flurbiprofen cilofen injection (5 ml): 50 mg/piece, intravenous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Patients will receive postoperative analgesic adjunctive therapy software to assist in pain control, with one postoperative analgesic adjunctive therapy software intervention at 24 hours and 48 hours after surgery, and pain evaluation within 30 minutes.
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
RECRUITINGMaoming People's Hospital
Maoming, Guangdong, China
RECRUITINGRuijing Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Numeric Rating Scale (NRS)
The NRS score is a commonly used postoperative pain assessment tool. The score uses a numeric scale from 0 to 10, on which patients are asked to mark their level of pain, with 0 being no pain and 10 being the most severe pain.
Time frame: The NRS evaluation is within 30 minutes of 24 and 48 hours after surgery.
Incidence of adverse events
Any unfavorable medical occurrence during the course of the study, whether device-related or not, is an adverse event.
Time frame: Assessment of adverse events is completed within 2 days postoperatively
Incidence of serious adverse events
If an event occurs during the clinical study that results in death or serious deterioration of health status, it is judged to be a serious adverse event
Time frame: Assessment of serious adverse events is completed within 2 days postoperatively
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITING