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NCT Number: NCT04735614

Physical Stabilization in Post-VATS

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. IV PCA dose

    Time frame: 48 hours

    the accumulated IV PCA drug dose

  2. On-request oral painkiller dose

    Time frame: 48 hours

    the accumulated oral painkiller dose

  3. Complications during hospital stay

    Time frame: 48 hours

    Any complications related to ThoraxBelt or not

  4. Length of hospital stay

    Time frame: 1 month

    The number of days in the hospital stay.

  5. The number of unanticipated events

    Time frame: 1 month

    The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups.

  6. Visual analog scale in outpatient clinic follow-up

    Time frame: 6 months

    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.

  7. Compliance of ThoraxBelt after discharge

    Time frame: 2 months

    How long is the ThoraxBelt removed except during bath in a day. The unit is hour.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 3, 2021
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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