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.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Lung Cancer
• Intervention / Treatment: Device: Posthorax Thoraxbelt

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • National Taiwan University Hospital Hsin-Chu Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ThoraxBelt; Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.	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.
No Intervention: Standard care; 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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): December 24, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: VATS; patient-controlled analgesia; video-assisted thoracoscopic surgery; visual analogue scale; post-operation pain control; Posthorax Thoraxbelt
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 109-118-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently, we have no plan on sharing the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No