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A prospective, double-blinded, randomized controlled trial to evaluate the efficacy of intravenous nefopam on postoperative opioid consumption after laparoscopic liver surgery

A prospective, double-blinded, randomized controlled trial to evaluate the efficacy of intravenous nefopam on postoperative opioid consumption after laparoscopic liver surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230428001
Enrollment
104
Registered
2023-04-28
Start date
2023-04-04
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients after laparoscopic liver surgery Nefopam, Laparoscopic liver surgery, Postoperative pain, Opioid consumption

Interventions

20 mg of nefopam diluted in 0.9%NSS up to 100 ml IV drip in 30 minutes at the end of surgery and then 60 mg of nefopam diluted in 0.9%NSS up to 500 ml IV continuous for 24 hours,receiving placebo as i
Active Comparator Drug,Placebo Comparator No treatment

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old 2. Patient who undergoing laparoscopic liver surgery 3. ASA classification I-III

Exclusion criteria

Exclusion criteria: 1. Severe systemic medical condition such as poor-controlled hypertension, heart disease, lung disease, renal dysfunction with GFR less than 60, poor-controlled diabetes mellitus, Child-Pugh class B or C, Abnormal liver function test (total bilirubin > 2 mg/dL, INR > 1.7, albumin < 3,5 g/dL, or aspartate or alanine aminotransferase > 2 times of upper limit of normal), neuromuscular disease 2. Chronic pain problem 3. Prescribed analgesic drugs 4. Contraindication to nefopam such as tachyarrhythmia, pregnancy, convulsive disorder, taking monoamine oxidase inhibitors 5. Allergic to study drugs 6. Unable or refusal to use IV PCA 7. Unable to understand and report numeric rating pain score 8. Anesthetic care personnel plan to do neuraxial or trunk blocks

Design outcomes

Primary

MeasureTime frame
Cumulative morphine consumption in 24 hours At 24 hours postoperatively Data from IV PCA machine

Secondary

MeasureTime frame
Postoperative pain score At 0, 1, 6, 12, 24, 48 hours postoperatively Numeric rating scale,Incidence of adverse effects During 24 hours postoperatively Dry mouth, profuse sweating, nausea, and vomiting

Countries

Thailand

Contacts

Public ContactPeerapong Sangsungnern

Faculty of Medicine, Khon Kaen University

peersa@kku.ac.th043348390

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026