Physical Stabilization in Post-VATS
Primary Purpose
Lung Cancer, Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Posthorax Thoraxbelt
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring video-assisted thoracoscopic surgery, VATS, post-operation pain control, patient-controlled analgesia, visual analogue scale, Posthorax Thoraxbelt
Eligibility Criteria
Inclusion Criteria:
- Operable lung cancer
- Eligible for video-assisted thoracoscopic surgery
Exclusion Criteria:
- Known allergy to ThoraxBelt
- Chest wall Infection or other diseases
- Pregnancy
Sites / Locations
- National Taiwan University Hospital Hsin-Chu Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ThoraxBelt
Standard care
Arm Description
Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.
Standard care with IV PCA and on-request oral painkiller.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
IV PCA dose
the accumulated IV PCA drug dose
On-request oral painkiller dose
the accumulated oral painkiller dose
Complications during hospital stay
Any complications related to ThoraxBelt or not
Length of hospital stay
The number of days in the hospital stay.
The number of unanticipated events
The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups.
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.
Compliance of ThoraxBelt after discharge
How long is the ThoraxBelt removed except during bath in a day. The unit is hour.
Full Information
NCT ID
NCT04735614
First Posted
January 19, 2021
Last Updated
December 9, 2022
Sponsor
National Taiwan University Hospital Hsin-Chu Branch
1. Study Identification
Unique Protocol Identification Number
NCT04735614
Brief Title
Physical Stabilization in Post-VATS
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital Hsin-Chu Branch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
The accumulated dose of the intervenous patient-controlled analgesic drug.
The dose of oral painkiller administered during the hospital stay.
Complications related to the ThoraxBelt.
Hospital stay
VAS before discharge
Unanticipated events (ICU admission, a second surgery, death)
VAS during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery.
Compliance on ThoraxBelt.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Pain, Postoperative
Keywords
video-assisted thoracoscopic surgery, VATS, post-operation pain control, patient-controlled analgesia, visual analogue scale, Posthorax Thoraxbelt
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The surgeon will not know the patients' group before or during the surgery. The outcome assessor won't know the group during the whole research.
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ThoraxBelt
Arm Type
Experimental
Arm Description
Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care with IV PCA and on-request oral painkiller.
Intervention Type
Device
Intervention Name(s)
Posthorax Thoraxbelt
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analog scale(VAS)
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
IV PCA dose
Description
the accumulated IV PCA drug dose
Time Frame
48 hours
Title
On-request oral painkiller dose
Description
the accumulated oral painkiller dose
Time Frame
48 hours
Title
Complications during hospital stay
Description
Any complications related to ThoraxBelt or not
Time Frame
48 hours
Title
Length of hospital stay
Description
The number of days in the hospital stay.
Time Frame
1 month
Title
The number of unanticipated events
Description
The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups.
Time Frame
1 month
Title
Visual analog scale in outpatient clinic follow-up
Description
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.
Time Frame
6 months
Title
Compliance of ThoraxBelt after discharge
Description
How long is the ThoraxBelt removed except during bath in a day. The unit is hour.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Operable lung cancer
Eligible for video-assisted thoracoscopic surgery
Exclusion Criteria:
Known allergy to ThoraxBelt
Chest wall Infection or other diseases
Pregnancy
Facility Information:
Facility Name
National Taiwan University Hospital Hsin-Chu Branch
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently, we have no plan on sharing the IPD.
Learn more about this trial
Physical Stabilization in Post-VATS
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