NCT04735614

Physical Stabilization in Post-VATS

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Lung Cancer
• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	Posthorax Thoraxbelt	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.

Timeline

• Start date: 2021-01-27
• Primary completion: 2021-12-24
• Completion: 2022-06-30
• First posted: 2021-02-03
• Last updated: 2022-12-12

Locations

1 site across 1 country: Taiwan