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Clinical Trial Summary

Background: Post-video-assisted thoracic surgery (VATS) pain remains an open issue, though most patients experience less acute pain after VATS than thoracotomy. So far, there was no gold standard regarding pain control post-VATS. Objective: To conduct a randomized controlled trial assessing the effect of physical thoracic stabilization on post-VATS pain control. Method: The investigators aimed to recruit 40 patients with operable lung cancer in the outpatient clinic from January to December 2021. The patients will be randomized into the intervention or control group. The intervention group will receive physical thoracic stabilization with POSTHORAX ThoraxBelt after the surgery, whereas the control group will have standard care. The follow-up period will last for 6 months.


Clinical Trial Description

The study has been approved by the hospital research ethics committee. Arm 1: Physical thoracic stabilization with ThoraxBelt after VATS Arm 2: Standard care after VATS Primary outcome: Visual analog scale (VAS) 6 hours, 24 hours, and 48 hours after the surgery. Secondary outcomes: 1. The accumulated dose of the intervenous patient-controlled analgesic drug. 2. The dose of oral painkiller administered during the hospital stay. 3. Complications related to the ThoraxBelt. 4. Hospital stay 5. VAS before discharge 6. Unanticipated events (ICU admission, a second surgery, death) 7. VAS during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery. 8. Compliance on ThoraxBelt. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04735614
Study type Interventional
Source National Taiwan University Hospital Hsin-Chu Branch
Contact
Status Completed
Phase N/A
Start date January 27, 2021
Completion date June 30, 2022

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