Clinical trial NCT04735614: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Pain, Postoperative
Keywords: video-assisted thoracoscopic surgery
VATS
post-operation pain control
patient-controlled analgesia
visual analogue scale
Posthorax Thoraxbelt
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Visual analog scale(VAS)
timeFrame: 48 hours
Secondary outcomes:
measure: IV PCA dose
timeFrame: 48 hours
measure: On-request oral painkiller dose
timeFrame: 48 hours
measure: Complications during hospital stay
timeFrame: 48 hours
measure: Length of hospital stay
timeFrame: 1 month
measure: The number of unanticipated events
timeFrame: 1 month
measure: Visual analog scale in outpatient clinic follow-up
timeFrame: 6 months
measure: Compliance of ThoraxBelt after discharge
timeFrame: 2 months
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
References: