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Single Preemptive Dose of Intravenous Nefopam Augmenting Multimodal Analgesia for Total Knee Arthroplasty: A Prospective, Triple-Blind, Randomized Controlled Trial

Single Preemptive Dose of Intravenous Nefopam Augmenting Multimodal Analgesia for Total Knee Arthroplasty: A Prospective, Triple-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251224005
Enrollment
60
Registered
2025-12-24
Start date
2025-10-01
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

Severe primary osteoarthritis of knee Preemptive analgesia, Multimodal analgesia, Enhanced Recovery After Surgery, Short-stay

Interventions

nefopam 20 mg mix with D5W 100 ml iv drip in 30 minutes before incision,D5W 100 ml iv drip in 30 minutes before incision
Experimental Drug,Placebo Comparator Drug

Sponsors

Buddhachinaraj hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patient diagnosed with primary knee OA Kellgrence-Lawrence stage 3,4 and scheduled for unilateral primary TKA 2.Underwent TKA with fixed-bearing posterior stabilized 3.Age 55-85 years old 4.ASA class I-III

Exclusion criteria

Exclusion criteria: 1.History of epilepsy, glaucoma, BPH 2.Severe hepatic or renal dysfunction 3.Use of MAOIs, SSRIs, or SNRIs 4.Allergy to nefopam or related drugs 5.Inability to undergo spinal anesthesia or adductor canal block 6.Previous surgery on the same knee 7.BMI more than 35 8.Cognitive impairment

Design outcomes

Primary

MeasureTime frame
visual analog scale 24 hours Regression analysis

Secondary

MeasureTime frame
morphine consumption 48 hours Regression analysis,Incidence of postoperative nausea and vomiting (PONV) 48 hours Risk regression model,Incidence of tachycardia 48 hours Risk regression model,Functional recovery (ROM, Time to first ambulation, TUG, Time to discharge) 48 hours Regression analysis,Oxford Knee Score 6 weeks Regression analysis,Patient satisfaction At discharge Regression analysis

Countries

Thailand

Contacts

Public ContactRatchaphon Khasemsiri

Buddhachinaraj hospital

ratchaphon.khasemsiri@gmail.com0949626398

Outcome results

None listed

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