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Clinical experience of patient-controlled analgesia using new device with micropump

Feasibility, safety and effectiveness of patient-controlled analgesia using new device with micropump

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062190015
Enrollment
5
Registered
2019-09-17
Start date
2020-02-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Patients who are eligible to start PCA after surgeries

Interventions

PCA using this device is planned to start after surgeries under general anesthesia

Sponsors

Shimizu Kazuyoshi
Lead Sponsor
DAIKEN MEDICAL CO., LTD.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following; 1)Patients who are eligible for PCA using this device intravenously or epidurally after operations under general anesthesia. 2)Age >= 20 and <80 3)Patients who undergo surgeries or procedures without public insurance 4)Patients who are able to obtain own consent by themselves 5) Patients who will admit to the Intensive Care Unit

Exclusion criteria

Exclusion criteria: Patients who meet at least one of the following; 1)Severe heart failure (NYHA class 3 or 4) 2)Severe respiratory failure (Hugh-Jones class 3 or 4) 3)Past history of psychiatric disease 4)Past allergic history of local anesthetics and narcotics 5)Withdraw consent before starting PCA 6)Pregnant and lactating women 7) Investigator judged to be inappropriate for this research In case of epidural PCA 8)Severe infection on the insertion site 9)Severe coagulopathy

Design outcomes

Primary

MeasureTime frame
A 5 grade evaluation about the feasibility of clinical use of this device assessed by users

Secondary

MeasureTime frame
1) Numerical rating scale (NRS) 2) Incidence of serious morbidities 3) Incidence of adverse events leading to serious morbidities

Contacts

Public ContactKazuyoshi Shimizu

Okayama University Hospital

kshimizu@sb4.so-net.ne.jp+81-86-235-7778

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026