Effect of nefopam infusion for postoperative multimodal analgesia in patients with contraindication to NSAIDs who undergo unilateral total knee replacement

Phase 4

• Conditions: nefopam infusion

• Registration Number: TCTR20210323005
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-23
• Study Completion: 2024-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Age 18 years old or more
2.Undergo unilateral TKA
3.ASA physical status I, II, III
4.Have a contraindication to NSAIDs (sulfonamide allergy, CAD, CVA, Creatinine Clearance less than 50 ml/min)
5.Able to use patient-controlled analgesia (IV PCA)
6.Understand the Thai language
7.Willing to enroll

Exclusion Criteria

1.Have a contraindication to nefopam: epilepsy, monoamine oxidase (MAO) inhibitors user, selective serotonin reuptake inhibitor user, glaucoma
2.Have a contraindication to regional anesthesia
3.Liver disease (Child-Pugh classification B or C)
4.Allergy to the drugs used in the research protocol: fentanyl, morphine, lidocaine, bupivacaine, paracetamol, dexamethasone, gabapentin
5.Chronic opioid use, drug abuse
6.Long-term use of NSAIDs, other drugs that may interfere with the research result

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
opioid consumption 48 hours postoperatively microgram of fentanyl from patient control analgesia device

Secondary Outcome Measures

Name	Time	Method
pain scores 48 hours postoperatively numerical rating score