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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Visual analog scale(VAS)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
- Length of hospital stay(1 month)
- IV PCA dose(48 hours)
- Complications during hospital stay(48 hours)
- The number of unanticipated events(1 month)
- On-request oral painkiller dose(48 hours)
- Visual analog scale in outpatient clinic follow-up(6 months)
- Compliance of ThoraxBelt after discharge(2 months)