Physical Stabilization in Post-VATS

National Taiwan University Hospital Hsin-Chu Branch

Status: Completed

Conditions: Pain, Postoperative; Lung Cancer

Treatments: Device: Posthorax Thoraxbelt

Study type: Interventional

Funder types: Other

Identifiers

NCT04735614

109-118-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Operable lung cancer
• Eligible for video-assisted thoracoscopic surgery

Exclusion criteria

• Known allergy to ThoraxBelt
• Chest wall Infection or other diseases
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

ThoraxBelt

Experimental group

Description:

Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.

Treatment:

Device: Posthorax Thoraxbelt

Standard care

No Intervention group

Description:

Standard care with IV PCA and on-request oral painkiller.