A Phase IV, single-center, open-label, randomized trial to evaluate clinical efficacy and safety of Maxigesic® injection in patients with analgesia after robotic urologic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011330

Enrollment

100

Registered

2025-12-15

Start date

2026-01-26

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

None listed

Interventions

Drug : This clinical trial is a single-center, randomized, open, and phase 4 clinical trial to evaluate the effectiveness and side effects of pain relief between IV PCA administration with Maxigesic®

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 19 years of age and under 80 years of age ? Patients who are scheduled to undergo urological surgery using robots (robot-assisted radical prostatectomy, robot-assisted partial nephrectomy) ? a patient who voluntarily agrees in writing to participate in this clinical trial

Exclusion criteria

Exclusion criteria: ? Patients who are hypersensitivity to the main ingredient or additive of this drug or to aspirin or other nonsteroidal anti-inflammatory drugs(NSAIDs) ? Patients with active alcoholism ? Patients with gastrointestinal ulcers, gastrointestinal bleeding, or a history of such conditions ? patients with severe blood disorders, liver disorders, and renal disorders ? a patient with severe hypertension, a patient with severe heart failure ? a patient with bronchial asthma or a history of it ? Patients who have taken the following medications: Barbital drugs, tricyclic antidepressants ? a patient on high-dose methotrexate as chemotherapy ? Pregnant women and breastfeeding women ? A person deemed unsuitable for clinical trials at the investigator's discretion

Design outcomes

Primary

Measure	Time frame
NRS Pain score evaluation within 48 hours after surgery	—

Secondary

Measure	Time frame
Numerical Rating Scale pain assessments at preoperatively and at 6, 24 and 48 hours post-surgery;Types and dosages of analgesics administered within 48 hours post-surgery;Types and dasages of antiemetics administered within 48 hours post-surgery;Non-administration / discontinuation of scheduled analgesics and reason in each group	—

Countries

Korea, Republic of

Contacts

Public ContactGoya Choi

Samsung Medical Center

choiky_84@never.com+82-2-2148-9599

Outcome results