pain following transforaminal lumar interbody fusion (TLIF)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.After fully informed of the benefits and risks of the trial, patient agreed to participate in the trial and voluntarily signed the informed consent; 2. Aged 18-75 years; 3. Clinical manifestations of low back pain and / or lower extremity nerve root pain, and MRI and / or CT confirmed central canal stenosis, lateral recess stenosis or intervertebral foramen stenosis of L1-S1 vertebrae: (1) Lower extremity radiculopathy: pain and / or weakness or paralysis and / or at least one specific sensory abnormality in L1-S1 vertebral nerve root distribution area; (2) Neurogenic intermittent claudication - long time Leg pain and / or weakness and / or abnormal sensation when walking or standing; (3) Transforaminal lumbar decompression and interbody fusion (TLIF) of 1 or 2 segments is required; 4. Conservative treatment included physical therapy, pain medication and local block therapy were ineffective for at least 3 months; 5. The grade of American Society of anesthesiologists is classified as I-II; 6. Patient controlled analgesia device (PCA) can be used independently.
Exclusion criteria
Exclusion criteria: 1. Previous history of lumbar instrumentation implantation; 2. Known allergy to mannitol or contraindications for intravenous mannitol; 3. TLIF with more than 3 segments is required; 4. Meyerding grade III or higher lumbar spondylolisthesis; 5. Other degenerative joint diseases (such as shoulder, hip, knee) and neuromuscular diseases may limit the evaluation of some postoperative indicators (e.g. standing and walking time test (TUG)); 6. Patients with cervical and / or thoracic diseases need selective surgical treatment within 3 months after lumbar surgery; 7. Low back or lower extremity symptoms are caused by tumors in the lumbar spine or other parts; 8. Other systemic diseases (diabetes, severe osteoporosis, obesity (BMI > 35 kg / m2), liver and kidney dysfunction); 9. Systemic or local active or chronic infection, such as AIDS, syphilis, hepatitis; 10. Acute or severe mental illness (psychosis, severe affective disorder or schizophrenia); 11. Recent or previous history of alcohol, opioid or narcotic drug dependence; 12. Autoimmune diseases affecting musculoskeletal system (such as systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis); 13. Pregnant or ready to be pregnant; 14. For mental or physical reasons, they can't master the PCA device, or they can't answer the pain questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale (VAS) for back and leg; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry disability index (ODI);Timed Up and Go (TUG);Opioid use within 72 hours after surgery; | — |
Countries
China
Contacts
Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology