Lung Cancer, Pain, Postoperative
Conditions
Keywords
video-assisted thoracoscopic surgery, VATS, post-operation pain control, patient-controlled analgesia, visual analogue scale, Posthorax Thoraxbelt
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.
Interventions
DEVICEPosthorax 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.
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Operable lung cancer * Eligible for video-assisted thoracoscopic surgery
Exclusion criteria
* Known allergy to ThoraxBelt * Chest wall Infection or other diseases * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale(VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| IV PCA dose | 48 hours | the accumulated IV PCA drug dose |
| On-request oral painkiller dose | 48 hours | the accumulated oral painkiller dose |
| Complications during hospital stay | 48 hours | Any complications related to ThoraxBelt or not |
| The number of unanticipated events | 1 month | The number of unanticipated events including ICU admission, a second surgery or death will be documented in both groups. |
| Visual analog scale in outpatient clinic follow-up | 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. |
| Compliance of ThoraxBelt after discharge | 2 months | How long is the ThoraxBelt removed except during bath in a day. The unit is hour. |
| Length of hospital stay | 1 month | The number of days in the hospital stay. |
Countries
Taiwan
Outcome results
None listed