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Effect of Opiranserin as an Adjunct for Pain Control After Open Gastrectomy

Effect of Opiranserin as an Adjunct for Pain Control After Open Gastrectomy : A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0012115
Enrollment
54
Registered
2026-06-12
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

None listed

Interventions

Drug : [Intervention group] Opiranserin (Unafra®) 1000mg is diluted in normal saline to a total volume of 500ml and administered intravenously. Following completion of anesthesia induction, a loading

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients (aged 19 years or older) undergoing open gastrectomy

Exclusion criteria

Exclusion criteria: Patients with a history of allergy or hypersensitivity to local anesthetics, acetaminophen, fentanyl, opiranserin, or nefopam Patients with unstable angina or congestive heart failure, or those with QRS >200msec or QTcF >450msec on electrocardiogram Patients with moderate to severe renal impairment Patients with moderate to severe hepatic impairment Patients currently receiving drugs known to prolong PR or QRS intervals Patients currently receiving strong CYP3A4 inhibitors Patients currently receiving MAO inhibitors Patients with a history of epilepsy or seizures Patients with severe chronic pain prior to surgery Patients with a history of drug addiction Patients unable to independently operate patient-controlled analgesia (PCA) Patients with skin disease or infection at the WellPass application site Patients unable to follow instructions or respond to questionnaires due to cognitive impairment Patients unable to read the informed consent form Patients corresponding to vulnerable subjects

Design outcomes

Primary

MeasureTime frame
Total opioid consumption up to 12 hours postoperatively (MME)

Secondary

MeasureTime frame
analgesic consumption (MME) at each postoperative time point;Pain score at each time point;Time to First Rescue Analgesic;PONV score at each time point;postoperative quality of recovery

Countries

Korea, Republic of

Contacts

Public ContactJiwon Lee

Yonsei University Health System, Gangnam Severance Hospital

belief705@yuhs.ac+82-2-2019-6807

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 21, 2026