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The Effect of Physical Thoracic Stabilization on Pain Control in Patients Who Had a Lung Tumor and Received Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial.
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.
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.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
Start Date
January 27, 2021
Primary Completion Date
December 24, 2021
Completion Date
June 30, 2022
Last Updated
December 12, 2022
32
ACTUAL participants
Posthorax Thoraxbelt
DEVICE
Lead Sponsor
National Taiwan University Hospital Hsin-Chu Branch
NCT06498635
NCT06066138
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