single-segment lumbar fusion
Conditions
Interventions
Duloxetine:duloxetine 60mg/day with standard analgesic regimen
Control:standard analgesic regimen
Sponsors
The Third People's Hospital of Chengdu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subjects volunteered to participate in the study and signed informed consent; 2 18-70 years old, male or female; 3 Inpatients undergoing elective single-segment lumbar fusion procedures; 4 history of chronic low back pain >= 3 months; 5 With central sensitization (central sensitization Inventory [CSI scale] score >= 40 points); 6 ASA physical status I–II.
Exclusion criteria
Exclusion criteria: 1. Allergic to the study drug duloxetine; 2. Has history of increased intraocular pressure or narrow-angle glaucoma; 3. Has other systemic diseases, including serious diseases of important organs such as heart, brain, lung, liver or kidney, immune diseases, metabolic diseases (diabetes, thyroid disease) or malignant tumors, reproductive system diseases such as ovarian cyst , Endometriosis, etc .; 4. Significant abnormalities in laboratory tests or electrocardiograms, such as: A. hemoglobin = 133umol / L (male) or >= 124umol / L (female); or creatinine clearance rate 1.5xULN and / or ALT> 1.5xULN and / or total bilirubin> 1.5 x ULN; 5. Patients with moderate to severe depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score > 9); 6. Patients with moderate to severe anxiety symptoms (Generalized Anxiety Disease-7 [GAD-7] score > 5); 7. History of other mental disorders such as schizophrenia, bipolar disorder, etc .; 8. History of drug or alcohol abuse; 9. Treatment with MAO inhibitor within 14 days prior to registration; 10. Long-term use or abuse of analgesics or opioids; 11. Treatment with duloxetine prior to registration; 12. Obese (BMI >= 40kg / m2); 13. Noncooperation ; 14. Pregnant or breast-feeding; 15. Participated in other studies in the last 3 months; 16. Other situations that investigators considered as unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life;recovery;sleep;satisfaction;mental health;postoperative opioid consumption reduction; | — |
Countries
China
Contacts
Public ContactLi Xue
Department of Orthopedics, the Third People's Hospital of Chengdu
Outcome results
None listed