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A Clinical Trial to Evaluate the Analgesic Efficacy and Safety of Nefopam(Acupan®) Compared to Oxycodone (Oxynorm®) in Postoperative Intravenous Patient-Controlled Analgesia of Patients Undergoing General Surgery

A Clinical Trial to Evaluate the Analgesic Efficacy and Safety of Nefopam(Acupan®) Compared to Oxycodone (Oxynorm®) in Postoperative Intravenous Patient-Controlled Analgesia of Patients Undergoing General Surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0003896
Enrollment
246
Registered
2019-05-08
Start date
2016-12-19
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

None listed

Interventions

Drug : At the end of the operation, an intravenous patient-controlled analgesia (IV PCA) pump with a baseline infusion rate of 1 ml/h, bolus injection volume of 1 ml and a lock-time of 15 minutes is c

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients undergoing general anesthesia under laparoscopic gastrointestinal or colorectal surgery - Patients who applied for postoperative intravenous patient-controlled analgesia - American Society of Anesthesiologists Physical Status 1, 2, and 3

Exclusion criteria

Exclusion criteria: - Patients taking pain medication preoperatively - Patients who are anaphylactic to nefopam or oxycodone - Patients with estimated glomerular filtration rate <60 ml / min / 1.73 m2 - Patients with a history of epilepsy - Patients with a history of ischemic heart disease - Patients taking monoamine oxidase inhibitor - Patients with walking disorders - Patients who can not press the analgesic administration button themselves for pain relief when there is postoperative pain due to impaired cognitive function or comprehension.

Design outcomes

Primary

MeasureTime frame
postoperative 24 hour visual analgoue scale value for pain

Secondary

MeasureTime frame
postoperative 6 hour visual analgoue scale value for pain;analgesics dose;Rhodes Index of Nausea, Vomiting, and Retching;Sedation scale;respiratory depression;Excessive sweating

Countries

Korea, Republic of

Contacts

Public ContactYong-Hun Lee

Asan Medical Center

yhlee0314@gmail.com+82-2-3010-3879

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 27, 2026