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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
32
The patients will be assisted to put on the ThoraxBelt after the surgery by our research member and will be asked to keep it on except for during showering through the whole study period.
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan
Visual analog scale(VAS)
A pain score will be assigned to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, which 10 indicated the most pain.
Time frame: 48 hours
IV PCA dose
the accumulated IV PCA drug dose
Time frame: 48 hours
On-request oral painkiller dose
the accumulated oral painkiller dose
Time frame: 48 hours
Complications during hospital stay
Any complications related to ThoraxBelt or not
Time frame: 48 hours
Length of hospital stay
The number of days in the hospital stay.
Time frame: 1 month
The number of unanticipated events
The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups.
Time frame: 1 month
Visual analog scale in outpatient clinic follow-up
follow-up 2-week, 1-month, and 6-month after discharge. The minimum is 0 and the maximum is 10, which 10 indicated the most pain.
Time frame: 6 months
Compliance of ThoraxBelt after discharge
How long is the ThoraxBelt removed except during bath in a day. The unit is hour.
Time frame: 2 months
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