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A study to confirm the clinical efficacy and safety using Maxigesic® injection in patients with postoperative analgesia after surgery on orthopedics.

A single institution, open, prospective observational study to confirm the clinical efficacy and safety using Maxigesic® injection in patients with postoperative analgesia after surgery on orthopedics.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011395
Enrollment
1000
Registered
2025-12-31
Start date
2023-10-24
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

None listed

Sponsors

Kyongbo Parm
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A person between the ages of 19 and less than 80 years of age 2) A person who is scheduled to undergo orthopedic surgery, such as hip, knee, water, foot, etc 3) Those who fall under the American Society of Anesthesiology's body classification grade I-III

Exclusion criteria

Exclusion criteria: 1) A person who has a history of allergic reactions or clinically significant hypersensitivity to drugs such as acetaminophen, ibuprofen, aspirin, opioid-like drugs or all nonsteroidal anti-inflammatory drugs (NSAIDs) 2) A person who needs continuous administration of opium-like drugs due to chronic pain 3) Those who have restrictive requirements for orthopedic surgery are applicable even if there is only one of the following. - Anyone who needs surgery with Open facture - Patients with a wide area of infection or active chronic infection or HIV infection 4) a person diagnosed with moderate liver and renal disease 5) A person who has not voluntarily agreed to participate in this clinical study 6) Other persons who are unable to participate in clinical research according to the judgment of the clinician

Design outcomes

Primary

MeasureTime frame
Changes in the Numeric Pain Rating Scale (0 points indicates no pain, 1-3 points indicates mild pain, 4-6 points indicates moderate pain, and 7-10 points indicates severe pain)

Secondary

MeasureTime frame
Total dosage of opioid analgesics administered as rescue medication, recorded in milligrams as Morphine Milligram Equivalent;Time to first administration of opioid analgesics as rescue medication;Incidence of complications such as nausea and vomiting;Discontinuation rate of medication due to adverse events;Discontinuation rate of medication based on satisfaction with pain control;The frequency of the patient's analgesic requests

Countries

Korea, Republic of

Contacts

Public ContactWoong-Kyo Jeong

Korea University Anam Hospital

drshoulder@korea.ac.kr+82-2-920-6779

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026