Physical Stabilization in Post-VATS

Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735614
• Other study ID #: 109-118-F
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2022
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Operable lung cancer

• Eligible for video-assisted thoracoscopic surgery

Exclusion Criteria:

• Known allergy to ThoraxBelt

• Chest wall Infection or other diseases

• Pregnancy

Related Conditions & MeSH terms

• Lung Cancer
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsin-Chu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IV PCA dose	the accumulated IV PCA drug dose	48 hours
Secondary	On-request oral painkiller dose	the accumulated oral painkiller dose	48 hours
Secondary	Complications during hospital stay	Any complications related to ThoraxBelt or not	48 hours
Secondary	Length of hospital stay	The number of days in the hospital stay.	1 month
Secondary	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
Secondary	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
Secondary	Compliance of ThoraxBelt after discharge	How long is the ThoraxBelt removed except during bath in a day. The unit is hour.	2 months