The effectiveness of variable-rate feedback infusion using dual channel elastomeric pump for intravenous patient-controlled analgesia in the patients with traumatic fractures: a randomized, double-blind, prospective study

The effectiveness of variable-rate feedback infusion using dual channel elastomeric pump for intravenous patient-controlled analgesia in the patients with traumatic fractures: a randomized, double-blind, prospective study - Efficacy of dual channel IV-PCA in trauma patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039952

Enrollment

Registered

2020-03-26

Start date

2020-03-30

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

Trauma adult patients (20-64 years) undergoing orthopedic surgery

Interventions

Interventions: Fentanyl based PCA in both &quot

continuos channel (constant flow channel

fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 2ml/hr)&quot

and &quot

Selector &amp

bolus channel (adjustable flow channel

fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 1(0-2)ml/hr)&quot

Control: Fentanyl based PCA in both &quot

continuous &amp

bolus channel (another constant flow channel

fentanyl 10 ug/kg + ramosetron 0.3mg, total 100ml, 1 ml/hr)&quot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I-III traumatic patients expecting a scheduled orthopedic surgery

Exclusion criteria

Exclusion criteria: BMI at or above 35, drug abuse, allergy history in fentanyl and ramosetron, dementia, psychiatric disease, communication problem, severe chronic pain, and incapable of decision making

Design outcomes

Primary

Measure	Time frame
Opioid(fentanyl) consumption after surgery (post-op 6, 12, 24, 36, 48 hours)	—

Secondary

Measure	Time frame
Pain score(Verbal numeric rating scale) rescue analgesic (ketorolac) patient satisfaction recovery scores including RASS, CAM-ICU and PARS adverse events including PONV	—

Countries

Asia(except Japan)

Contacts

Public ContactYoung Sung Kim

Korea University Guro Hospital Department of Anesthesiology and Pain medicine

stelios@naver.com82-2-2626-1437

Outcome results

None listed

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