Additional nefopam reduces postoperative pain after primary total knee arthroplasty: a randomized controlled trial

Phase 4

Completed

• Conditions: Total knee arthroplastyPainNefopam; Total knee arthroplasty; Pain; Nefopam

• Registration Number: TCTR20220814002
• Lead Sponsor: Phyathai 3 Hospital

Brief Summary

Patients in nefopam group had higher pain score and higher amount of morphine consumption at 24 hours postoperative as well as difference in overall pain. Neither the amount of morphine consumption at other time points nor the knee range of motion differed between two groups.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-03-31
• Study Start: 2022-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1 Primary OA knee
2 Age between 50 to 85 years
3 Fully comprehension of Thai language

Exclusion Criteria

1 Previous ipsilateral knee surgery
2 Contraindication to drugs used in the study (nefopam, ketorolac, parecoxib, paracetamol, tranexamic acid)
3 Chronic kidney disease which GFR <50 ml/min
4 Arrhythmic heart disease
5 Psychiatric disorder receiving serotonin or tramadol
6 Intraoperative fracture or ligamentous injury

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score at rest 6, 12, 18, 24, 36 and 48 hours postoperative Numerical rating scale score (NRS)

Secondary Outcome Measures

Name	Time	Method
Morphine consumption 6, 12, 18, 24, 36 and 48 hours postoperative Mg