Multicenter RCT Pilot Study of Amy-PCA
- Conditions
- ung cancer, metastatic lung cancerThoracic surgery
- Registration Number
- JPRN-jRCTs062210006
- Lead Sponsor
- Yamakage Michiaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
Patients who meet all of the following;
1.Patients with lung cancer and metastatic cancer including open thoracotomy, laparoscopic surgery, robot-assisted surgery)
2.Patients with moderate pain (NRS3>=10) at surgical site preoperatively
3.Patients who are eligible for PCA using this device intravenously or epidurally after operations under general anesthesia.
4.Patients who will stay at hospital for at least three days
5.Age >= 20
6.Patients who live by themselves freely without any problems
7.Patients who can understand and accept this study by themselves fully after receiving enough explanation
1) Pregnant and lactating women
2) Past allergic history of local anesthetics and narcotics
3) Severe heart failure(NYHA class>=3)
4) Severe respiratory failure(Hugh Jones class>=3)
5) Past history of hemodialysis
6) Past history of liver cirrhosis(Child-Pugh C)
7) Past history of delirium
8) American Society of Anesthesiologists physical status(ASA)>=4
9) Investigator(responsible person or contributory person) thought that their participation didn't cause most beneficical effect such as losing welfare, preventing or limiting or confusing reasonable assessment.
[Investigator judged to be inappropriate for this research in case of epidural PCA]
10) Severe infection on the insertion site
11) PT-INR>2.0 or Platelet<70000/ul
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RS at rest POD1
- Secondary Outcome Measures
Name Time Method 1.Satisfaction assessment: satisfaction for pain management <br>2.Comparison for PCA machine (easy to use)<br>3.NRS at movement<br>4.Usage of other analgesics<br>5.Frequency of disease or machine's trouble <br>6.Recovery information (walk, drink, eat, unnecessity for PCA(applied to the order of PCA withdrwal)<br>7.Hospital stay