Physical Stabilization in Post-VATS

NCT04735614 | Completed

• 1 other identifier: 109-118-F
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Pain, Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• IV PCA dose

  48 hours

• On-request oral painkiller dose

  48 hours

• Complications during hospital stay

  48 hours

• Length of hospital stay

  1 month

• The number of unanticipated events

  1 month

Study Arms (2)

ThoraxBelt

EXPERIMENTAL

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

Device: Posthorax Thoraxbelt

Standard care

NO INTERVENTION

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

Interventions

Posthorax Thoraxbelt 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.

ThoraxBelt

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known allergy to ThoraxBelt
• Chest wall Infection or other diseases
• Pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 39277837 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 3, 2021
• Study Start: January 27, 2021
• Primary Completion: December 24, 2021
• Study Completion: June 30, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)