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Efficacy of Nefopam as a Multimodal Analgesic Agent in Acute Post-Operative Pain Control After Total Knee Arthroplasty – A Randomized Control Trial

Efficacy of Nefopam as a Multimodal Analgesic Agent in Acute Post-Operative Pain Control After Total Knee Arthroplasty – A Randomized Control Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200410009
Enrollment
Unknown
Registered
2020-04-10
Start date
2020-04-08
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

Primary osteoarthritis of the knee Nefopam Total knee arthroplasty Multimodal analgesia

Interventions

The volunteers will be given nefopam 80mg + 5%DW 500 ml intravenous drip in 24h from time 0 (at PACU) to 24 h post&#45
op,The volunteers will be given 5%DW 500 ml intravenous drip in 24h from time 0 (at PACU) to 24 h post&#45
Experimental Drug,Placebo Comparator No treatment

Sponsors

Faculty of Medicine, Thammasat University
Lead Sponsor
Faculty of Medicine&#44
Collaborator
Thammasat University
Collaborator

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patient diagnosed primary OA knee and needed surgery Age 55-80 years ASA class I-III Understand the protocol and volunteered to join the study

Exclusion criteria

Exclusion criteria: Cannot undertaken spinal block and adductor canal block Allergy to study drugs (nefopam & other drugs in standard order) Have previous surgery on the same side of TKA knee (such as knee arthroscopy&#44; UKA&#44; HTO&#44; fracture fixation) Renal insufficiency (CCr <30ml/min) History of convulsive disorder History of stroke or intracranial surgery Abnormal liver function (Child&#45;Pugh score C) History of glaucoma&#44; BPH Taking MAOIs&#44; TCAs&#44; SSRIs&#44; SNRIs

Design outcomes

Primary

MeasureTime frame
100mm VAS 6&#44;12&#44;18&#44;24&#44;30&#44;36&#44;48 h post operative at rest and motion patient will mark the VAS on the 100mm line&#44; left end = no pain&#44; right end = unimaginable pain

Secondary

MeasureTime frame
Morphine consumption 0&#45;48 h post&#45;op mg,Adverse effect 0&#45;48 h post&#45;op n&#44; percentage,Range of motion 24&#44;48 h post&#45;op degree&#44; line from greater trochanter to knee to line along anterior tibia,Timed up and go test 48h post&#45;op second,Time to walk from post&#45;op to discharge hours post&#45;op,Time to discharge when volunteer has VAS 12 h hours,sedation score 12&#44; 24&#44; 36&#44;48 h post&#45;op 0&#45;3 ,satisfactory score 12&#44; 24&#44; 36&#44;48 h post&#45;op 0&#45;3

Countries

Thailand

Contacts

Public ContactPiya Pinsornsak

Department of Orthopaedics&#44; Faculty of Medicine&#44; Thammasat University

pinpiya2003@yahoo.com084-639-2078

Outcome results

None listed

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