Multicenter RCT Pilot Study of Amy-PCA

JRCT ID: jRCTs062210006

Registered date:26/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung cancer, metastatic lung cancer
• Date of first enrollment: 11/01/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

1) Allocated PCA machine(conventional or COOPDECH Amy)will be started at surgery irrespective of injection type (venous or epidural)
2) Setting and medicine for PCA will be organized based on individual institution
3) Survey regarding satisfaction will be conducted to participants the day before withdrawal of PCA machine
4) PCA will be withdrawal according to postoperative course
Criteria of PCA withdrawal
1 Good controlled pain (unnecessary for PCA bolus)
2 Possible of drinking and meal and unnecessary for injection
3 Strong side effect for PCA (Yes/No regarding nausea, vomiting, dizziness and drowsiness), (decreased respiratory rate below 8 times/minute)
5) Exchange for PCA pump if possible (COOPDECH; Conventional or Conventional; COOPDECH) the day before PCA withdrawal under individual patient's approval.(from COOPDECH Amy-PCA to conventional machine or from conventional machine to COOPDECH Amy-PCA)
6) Assessment (Survey) for PCA machine will be conducted to participants who exchanged PCA machine at the timing of withdrawal of PCA machine

Outcome(s)

• Primary Outcome: NRS at rest POD1

Secondary Outcome

1.Satisfaction assessment: satisfaction for pain management
2.Comparison for PCA machine (easy to use)
3.NRS at movement
4.Usage of other analgesics
5.Frequency of disease or machine's trouble
6.Recovery information (walk, drink, eat, unnecessity for PCA(applied to the order of PCA withdrwal)
7.Hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Yamakage Michiaki
• Source(s) of Monetary Support: Daiken Medical CO.,LTD,Daiken Medical CO. LTD