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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ThoraxBelt | Experimental | Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm. |
|
| Standard care | No Intervention | Standard care with IV PCA and on-request oral painkiller. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posthorax Thoraxbelt | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| IV PCA dose | the accumulated IV PCA drug dose | 48 hours |
| On-request oral painkiller dose | the accumulated oral painkiller dose | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch | Hsinchu | 300 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39277837 | Derived | Fan CY, Lin CW, Sung CW, Huang EP. Therapeutic potential of physical stabilization in VATS pain control: a randomized controlled trial. Updates Surg. 2025 Jan;77(1):193-199. doi: 10.1007/s13304-024-01999-w. Epub 2024 Sep 15. |
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Currently, we have no plan on sharing the IPD.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The surgeon will not know the patients' group before or during the surgery. The outcome assessor won't know the group during the whole research.
| Complications during hospital stay | Any complications related to ThoraxBelt or not | 48 hours |
| Length of hospital stay | The number of days in the hospital stay. | 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. | 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. | 6 months |
| Compliance of ThoraxBelt after discharge | How long is the ThoraxBelt removed except during bath in a day. The unit is hour. | 2 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |