Physical Stabilization in Post-VATS

Not Applicable

Completed

• Conditions: Lung Cancer; Pain, Postoperative
• Interventions: Device: Posthorax Thoraxbelt

• Registration Number: NCT04735614
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

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:

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 Timeline

• Study First Submitted: 2021-01-19
• Study Start: 2021-01-27
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-03
• Primary Completion: 2021-12-24
• Study Completion: 2022-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ThoraxBelt	Posthorax Thoraxbelt	Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.

Primary Outcome Measures

Name	Time	Method
Visual analog scale(VAS)	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Complications during hospital stay	48 hours	Any complications related to ThoraxBelt or not
Length of hospital stay	1 month	The number of days in the hospital stay.
IV PCA dose	48 hours	the accumulated IV PCA drug dose
The number of unanticipated events	1 month	The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups.
On-request oral painkiller dose	48 hours	the accumulated oral painkiller dose
Visual analog scale in outpatient clinic follow-up	6 months	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.
Compliance of ThoraxBelt after discharge	2 months	How long is the ThoraxBelt removed except during bath in a day. The unit is hour.

Trial Locations

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch; 🇨🇳 Hsinchu, Taiwan