Clinical trial to evaluate clinical efficacy and safety of Maxigesic® injection in patients with analgesia after robotic urologic surgery

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

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0010368

Enrollment

150

Registered

2025-03-31

Start date

2025-07-16

Completion date

Unknown

Last updated

2025-09-22

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 is a phase IV, single-center, open-label, randomized trial to evaluate the efficacy and safety of Maxigesic®, and analgesics including opioid according to the CP(clinical pathway) after ro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Aged 19 years and older but under 80 years ? Patients scheduled to undergo robot-assisted urologic surgery (such as robot-assisted radical prostatectomy, robot-assisted partial nephrectomy, robot-assisted radical nephrectomy, or robot-assisted nephroureterectomy) ? Patients with an activity level sufficient for normal daily life (Eastern Cooperative Oncology Group performance status of 0 or 1) ? Patients who have voluntarily provided written consent to participate in the trial

Exclusion criteria

Exclusion criteria: ? Patients with hypersensitivity to the active substances, or to any of the excipients or 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 hematologic abnormality,liver dysfunction, or kidney dysfunction ? Patients with severe hypertension or severe heart failure ? Patients with bronchial asthma or a history of it ? Patients taking the following medications: barbiturates, tricyclic antidepressants ? Patients receiving high-dose methotrexate for cancer chemotherapy ? Pregnant or breastfeeding women ? Patients deemed unsuitable for clinical trials at the investigator’s discretion

Design outcomes

Primary

Measure	Time frame
Cumulative NRS pain assessment up to 48 hours after surgery	—

Secondary

Measure	Time frame
Amount(mcg) of Opioid(PCA Fentanyl) within 48 hours after surgery;Amount of rescue medication(pain control medication) used within 48 hours after surgery;NRS pain assessment at 6, 24, 48 hours after surgery;Amount of antiemetics used within 48 hours after surgery	—

Countries

Korea, Republic of

Contacts

Public ContactIn Gab Jeong

Asan Medical Center

igjeong@amc.seoul.kr+82-2-3010-5892

Outcome results