Efficacy of Duloxetine for Chronic postsurgical Pain after Total Hip Arthroplasty
- Conditions
- Health ConditionHip OsteoarthritisD015207
- Registration Number
- JPRN-jRCT1031210331
- Lead Sponsor
- ishi Masanori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
1) Patients who have osteoarthritis of hip
2) Aged more than 20 years
3) Persons who have not taken duloxetine or two weeks since last dose
4) Written informed consent
1) Persons with a history of hypersensitivity to the duloxetine
2) Persons administering monoamine oxidase (MAO) inhibitors
3) Persons administering medicines that have a strong inhibitory effect on CYP1A2
4) Persons with severe liver damage (ALAT or ASAT>100IU/L) , history of liver cirrhosis, or liver transplantation
5) Persons with renal damage (eGFR<30mL/min), renal transplantation, or dialysis therapy
6) Depression (HAM-D score > 7)
7) Persons with alcohol or other dependence within 5 years
8) Persons with severe cardiovascular disease
9) Hyponatremia (<135 nmol/L)
10) Persons with uncontrolled hypertension
11) Patients with glaucoma, thyroid disease, or epilepsy
12) Persons who are or may be pregnant
13) Persons with a history of hypersensitivity to the Non-Steroidal Anti-Inflammatory Drugs or aspirin-induced asthma.
14) Persons who are judged by the research-responsible (sharing) doctor to be inappropriate for participation in this research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in NRS after total hip arthroplasty
- Secondary Outcome Measures
Name Time Method Japanese Orthopaedic Association Hip-Disease Evaluation Questionnaire (JHEQ)<br>pain catastrophizing scale (PCS)<br>Merle d'Aubigne-Postel hip score (MDP)<br>Postoperative analgesics (excluding duloxetine)<br>Vitality Index