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Non-inferiority of Opiranserin compared to Acetaminophen as a component of Multimodal Analgesia for Postoperative Pain Management after minimally invasive cholecystectomy

Non-inferiority of Opiranserin compared to Acetaminophen as a component of Multimodal Analgesia for Postoperative Pain Management after minimally invasive cholecystectomy: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0011930
Enrollment
90
Registered
2026-05-04
Start date
2026-05-07
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

None listed

Interventions

Drug : 1) The research team will explain the study to those who meet the inclusion and exclusion criteria and allow them sufficient time to consider participating. Afterward, informed consent for stud

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 cholecystectomy

Exclusion criteria

Exclusion criteria: • Patients with a history of adverse reactions such as allergies to the medication • Patients with unstable angina, congestive heart failure, or an electrocardiogram showing QRS > 200 msec or QTcF > 450 msec • Patients with moderate to severe renal impairment • Patients with moderate to severe hepatic impairment • Patients currently taking medications known to increase the PR or QRS interval • Patients currently taking strong CYP3A4 inhibitors • Patients with chronic pain requiring analgesics • Patients with cognitive impairment • Pregnant or lactating women • Cases where the informed consent form cannot be understood (e.g., illiteracy, cognitive impairment, etc.)

Design outcomes

Primary

MeasureTime frame
AUC (Area Under the Curve) 12h of pain score

Secondary

MeasureTime frame
Cumulative opioid consumption at each time point;Pain score at each time point;Proportion of rescue-free patients up to each time point;Time to First Rescue Analgesic;PONV score at each time point;postoperative quality of recovery

Countries

Korea, Republic of

Contacts

Public ContactHyunjik Song

Yonsei University Health System, Gangnam Severance Hospital

anehjsong@gmail.com+82-2-2019-6097

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 11, 2026