Efficacy of Nefopam as a Multimodal Analgesic Agent in Acute Post-Operative Pain Control After Total Knee Arthroplasty †A Randomized Control Trial
Phase 4
Recruiting
- Conditions
- Primary osteoarthritis of the kneeNefopamTotal knee arthroplastyMultimodal analgesia
- Registration Number
- TCTR20200410009
- Lead Sponsor
- Faculty of Medicine, Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
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
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, UKA, HTO, fracture fixation)
Renal insufficiency (CCr <30ml/min)
History of convulsive disorder
History of stroke or intracranial surgery
Abnormal liver function (Child-Pugh score C)
History of glaucoma, BPH
Taking MAOIs, TCAs, SSRIs, SNRIs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 100mm VAS 6,12,18,24,30,36,48 h post operative at rest and motion patient will mark the VAS on the 100mm line, left end = no pain, right end = unimaginable pain
- Secondary Outcome Measures
Name Time Method Morphine consumption 0-48 h post-op mg,Adverse effect 0-48 h post-op n, percentage,Range of motion 24,48 h post-op degree, line from greater trochanter to knee to line along anterior tibia,Timed up and go test 48h post-op second,Time to walk from post-op to discharge hours post-op,Time to discharge when volunteer has VAS<2/10 while walking and no Foley's catherter and IV attached > 12 h hours,sedation score 12, 24, 36,48 h post-op 0-3 ,satisfactory score 12, 24, 36,48 h post-op 0-3