Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-02 @ 2:46 PM
Study NCT ID:
NCT06574451
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
Sponsor:
Guangdong Provincial People's Hospital
Organization:
Study Overview
Official Title:
Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain (VR-TSP)
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-TSP
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: