Physical Stabilization in Post-VATS

Study Overview
=================
Brief 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.

Detailed 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: The accumulated dose of the intervenous patient-controlled analgesic drug. The dose of oral painkiller administered during the hospital stay. Complications related to the ThoraxBelt. Hospital stay VAS before discharge Unanticipated events (ICU admission, a second surgery, death) VAS during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery. Compliance on ThoraxBelt.

Official Title
-----------------
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.

Conditions
-----------------
Lung Cancer, Pain, Postoperative

Intervention / Treatment
-----------------
* Device: Posthorax Thoraxbelt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operable lung cancer Eligible for video-assisted thoracoscopic surgery Exclusion Criteria: Known allergy to ThoraxBelt Chest wall Infection or other diseases Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ThoraxBelt<br>Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm. | Device: Posthorax Thoraxbelt<br>* 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.<br>|
| No Intervention: Standard care<br>Standard care with IV PCA and on-request oral painkiller. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
video-assisted thoracoscopic surgery, VATS, post-operation pain control, patient-controlled analgesia, visual analogue scale, Posthorax Thoraxbelt