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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011156

Enrollment

100

Registered

2025-11-13

Start date

2025-12-31

Completion date

Unknown

Last updated

2025-11-17

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 la

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Aged 19 years and older but under 80 years ? Patients scheduled to undergo laparoscopic or 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

Design outcomes

Primary

Measure	Time frame
Cumulative Numerical Rating Scale pain assessment within 48 hours post-surgery	—

Secondary

Measure	Time frame
Numerical Rating Scale pain assessments at preoperatively and at 6, 12, 18, 24, 30, 36, 42, and 48 hours post-surgery;Types and dosages of analgesics administered according to Clinical Pathway within 48 hours post-surgery;Types and dosages of antiemetics administered within 48 hours post-surgery;Cost-effectiveness evaluation of postoperative pain management between the Maxigesic IV® group and the opioid-containing Intravenous Patient-Controlled Analgesia group;Non-administration/discontinuation of scheduled analgesics and reasons in each group	—

Measure

Time frame

Numerical Rating Scale pain assessments at preoperatively and at 6, 12, 18, 24, 30, 36, 42, and 48 hours post-surgery;Types and dosages of analgesics administered according to Clinical Pathway within 48 hours post-surgery;Types and dosages of antiemetics administered within 48 hours post-surgery;Cost-effectiveness evaluation of postoperative pain management between the Maxigesic IV® group and the opioid-containing Intravenous Patient-Controlled Analgesia group;Non-administration/discontinuation of scheduled analgesics and reasons in each group

—

Countries

Korea, Republic of

Contacts

Public ContactSeung Hwan Lee

Yonsei University Health System, Severance Hospital

skidms@naver.com+82-2-2228-2324

Outcome results