Lung CancerNCT04735614
Physical Stabilization in Post-VATS
A study testing Posthorax Thoraxbelt in people with Lung Cancer and Pain, Postoperative, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Pain, Postoperative
- What is being tested?
- Posthorax Thoraxbelt
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operable lung cancer
- Eligible for video-assisted thoracoscopic surgery
Who cannot join
- Known allergy to ThoraxBelt
- Chest wall Infection or other diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Lung Cancer, Pain, Postoperative
- Being tested
- Posthorax Thoraxbelt
- Keywords
- video-assisted thoracoscopic surgery, VATS, post-operation pain control, patient-controlled analgesia, visual analogue scale, Posthorax Thoraxbelt
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posthorax ThoraxbeltDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ThoraxBelt | Experimental | Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm. Receives: Device: Posthorax Thoraxbelt |
| Standard care | No intervention | Standard care with IV PCA and on-request oral painkiller. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (7)
IV PCA dose
the accumulated IV PCA drug dose
Measured: 48 hours
On-request oral painkiller dose
the accumulated oral painkiller dose
Measured: 48 hours
Complications during hospital stay
Any complications related to ThoraxBelt or not
Measured: 48 hours
Length of hospital stay
The number of days in the hospital stay.
Measured: 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.
Measured: 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.
Measured: 6 months
Compliance of ThoraxBelt after discharge
How long is the ThoraxBelt removed except during bath in a day. The unit is hour.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start27 Jan 2021
- Primary completion24 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735614
- Sponsor's protocol ID
- 109-118-F
- Status last verified
- Dec 2022
- First submitted
- 19 Jan 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, we have no plan on sharing the IPD.
Publications
Fan CY, Lin CW, Sung CW, Huang EP. Therapeutic potential of physical stabilization in VATS pain control: a randomized controlled trial. Updates Surg. 2025 Jan;77(1):193-199. doi: 10.1007/s13304-024-01999-w. Epub 2024 Sep 15.
PubMed 39277837
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04735614
- Acronym / sponsor ID
- 109-118-F
- Conditions
- Lung Cancer, Pain, Postoperative
- Keywords
- video-assisted thoracoscopic surgery, VATS, post-operation pain control, patient-controlled analgesia, visual analogue scale, Posthorax Thoraxbelt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ThoraxBelt | Experimental | Device: Posthorax ThoraxbeltReceived ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm. |
| Standard care | No intervention | –Standard care with IV PCA and on-request oral painkiller. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Operable lung cancer
- Eligible for video-assisted thoracoscopic surgery
Key exclusion criteria (3 listed)
- Known allergy to ThoraxBelt
- Chest wall Infection or other diseases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posthorax ThoraxbeltThe 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. | Device | ThoraxBelt |
Primary outcome
Visual analog scale(VAS)
Time frame: 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.
7 secondary outcomes
IV PCA dose
Time frame: 48 hours
On-request oral painkiller dose
Time frame: 48 hours
Complications during hospital stay
Time frame: 48 hours
Length of hospital stay
Time frame: 1 month
The number of unanticipated events
Time frame: 1 month
Visual analog scale in outpatient clinic follow-up
Time frame: 6 months
Compliance of ThoraxBelt after discharge
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Derived from this study: PubMed 39277837Fan CY, Lin CW, Sung CW, Huang EP. Therapeutic potential of physical stabilization in VATS pain control: a randomized controlled trial. Updates Surg. 2025 Jan;77(1):193-199. doi: 10.1007/s13304-024-01999-w. Epub 2024 Sep 15.
- Individual participant dataSharing planned: No. Currently, we have no plan on sharing the IPD.
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posthorax Thoraxbelt in people with Lung Cancer and Pain, Postoperative, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale(VAS) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.