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Multicenter RCT Pilot Study of Amy-PCA

Open labeled multicenter randomized parallel group pilot study regarding the effectiveness of COOPDECH Amy Patient Controlled Analgesia for postoperative pain management after thoracic surgery - Multicenter RCT Study of Amy-PCA in thoracic surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062210006
Enrollment
100
Registered
2021-05-26
Start date
2022-01-11
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer, metastatic lung cancer Thoracic surgery

Interventions

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 individu
Conventional or Conventional
COOPDECH) the day before PCA withdrawal under individual patients approval.(from COOPDECH Amy-PCA to conventional machine or from conventional machine to COOPDECH Amy-PCA) 6) Assessment (Survey) for P

Sponsors

Yamakage Michiaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
NRS at rest POD1

Secondary

MeasureTime frame
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

Contacts

Public ContactShunsuke Tachibana

Sapporo Medical University Hospital

tachibana@sapmed.ac.jp+81-11-688-9663

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026