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Physical Stabilization in Post-VATS

NCT ID: NCT04735614

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer Pain, Postoperative

Keywords

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video-assisted thoracoscopic surgery VATS post-operation pain control patient-controlled analgesia visual analogue scale Posthorax Thoraxbelt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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ThoraxBelt

Received ThoraxBelt after the surgery. Standard care for pain management will be the same as the Standard Care Arm.

Group Type EXPERIMENTAL

Posthorax Thoraxbelt

Intervention Type DEVICE

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.

Standard care

Standard care with IV PCA and on-request oral painkiller.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known allergy to ThoraxBelt
* Chest wall Infection or other diseases
* Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 39277837 (View on PubMed)

Other Identifiers

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109-118-F

Identifier Type: -

Identifier Source: org_study_id