The efficacy of intermittent intravenous nefopam for postoperative pain control: Randomized Control Trial in robotic assisted-Total Knee Arthroplasty

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250901008

Enrollment

Registered

2025-09-01

Start date

2025-09-01

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

Postoperative pain in patients undergoing robotic-assisted total knee arthroplasty Nefopam Postoperative pain Robotic total knee arthroplasty

Interventions

Nefopam 20 mg diluted in NSS 100 ml IV drip in 2 hr q 6 hr for 24 hours,NSS 100 ml IV drip in 2 hr q 6 hr for 24 hours

Experimental Drug,Experimental Drug

Nefopam: NSS IV drip with nefopam (20 mg/dose),Placebo: NSS IV drip without nefopam

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. age between 40-80 years 2. patients who had symptomatic primary osteoarthritis knee were scheduled for robotic-assisted TKA 3. Able to communicate and make informed decisions independently

Exclusion criteria

Exclusion criteria: 1. History of convulsion 2. Cirrhosis from any cause 3. Impaired renal function (glomerular filtration rate 0-60 mL/min/1.73m2) 4. angle-closure glaucoma or benign prostatic hyperplasia 5. Prior knee infection 6. Ischemic heart disease 7. Patient who had known allergies to the drugs being used in the investigation (paracetamol, fentanyl, nefopam, aspirin) 8. Concomitant use with opioid derivatives (analgesics, anti-cough products and substitutive treatment), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, hypnotics, sedative antidepressants (TCAs, SSRIs and SNRI), sedative antihistaminic H1, central antihypertensive drugs, baclofen and thalidomide

Design outcomes

Primary

Measure	Time frame
Postoperative pain Postoperative day1,2 and follow up at 2 and 6 wks Verbal numerical rating scale	—

Secondary

Measure	Time frame
Postoperative opioid consumption Postoperative day 1 and 2 Medical record form,Functional outcome Postoperative day1 and 2 QOR-35 score ,Functional outcome Postoperative follow up 2 and 6 weeks Euro QOL 5D,Complication Postoperative day1,2 and follow up at 2 and 6 weeks Medical record form	—

Countries

Thailand

Contacts

Public ContactTarin Khaoropphan

Faculty of medicine, Prince of Songkhla university

6610370033@email.psu.ac.th0805249547

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026