Postoperative Complications, Postoperative Pain
Conditions
Keywords
VATS, lung lobectomy, postoperative pain, chest drain, analgesia
Brief summary
The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer. The main questions it aims to answer are: * silicone chest drains are less painful compared to standard PVC drains? * is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.
Interventions
DEVICESIL drain
Silicone chest tube used for pleural space drainage after VATS lobectomy
DEVICEPVC drain
Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary lung cancer eligible for VATS lobectomy by tumor board meeting
Exclusion criteria
* age under 18 years * high risk of post-operative complications (ASA \> 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) \< 15 ml/kg/min) * tumors growing in parietal pleura * extended lung resection diffuse * previous surgery in the same hemithorax * chronic pain * chronic use of analgesics or sedatives * surgical revision * inability to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesics consumption | 2 days | Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome. |
| Need for peroral analgesia after the chest tube removal | 2 days | Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome. |
| Maximal inspiratory pressure | 2 days | Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome. |
| Maximal expiratory pressure | 2 days | Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome. |
| Visual analogue scale | 2 days | Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subcutaneous emphysema rate | 1 month | The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome. |
| Prolonged air leak rate | 1 month | The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome. |
| Reintervention rate | 1 month | The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome. |
| Duration of chest drainage | 1 month | The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome. |
| Respiratory complication rate | 1 month | Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome. |
| Readmission rate | 1 month | Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome. |
| Duration of hospital stay | 1 month | Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome. |
| Pneumothorax rate on the day of surgery | First day | The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. |
| Pneumothorax rate after chest tube removal | 1 month | The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. |
| Pleural effusion rate on the day of surgery | First day | The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. |
| Pleural effusion rate after chest tube removal | 1 month | The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. |
Countries
Slovenia
Outcome results
None listed