Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574451
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Effectiveness and Safety of Adjuvant Software Based on Virtual Reality for Post-thoracoscopic Surgery Pain
Sponsor:
None
Organization:
None
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:
No
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 50mgstick4 sticks combined with Dezocine Injection 1ml 5mgstick6 sticks add Ondansetron Hydrochloride Injection 2ml 4mgstick2 sticks or add Tolisetron Mesylate Injection 2ml 6 mgstick4 sticks diluted to 100mL with 09 sodium chloride injectionIn 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 mgpiece 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 50mgstick4 sticks combined with Dezocine Injection 1ml 5mgstick6 sticks add Ondansetron Hydrochloride Injection 2ml 4mgstick2 sticks or add Tolisetron Mesylate Injection 2ml 6 mgstick4 sticks diluted to 100mL with 09 sodium chloride injectionIn 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 mgpiece intravenous injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None