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Effect of intravenous mannitol on post-operation pain following transforaminal lumar interbody fusion (TLIF)

A single center, prospective, randomized, controlled study of effect of intravenous mannitol on pain of lumbar and lower limbs following transforaminal lumar interbody fusion (TLIF)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039200
Enrollment
Unknown
Registered
2020-10-21
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain following transforaminal lumar interbody fusion (TLIF)

Interventions

experimental group:20% mannitol 0.5g/kg/day was injected intravenously for 3 days
control group:Nil

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
visual analogue scale (VAS) for back and leg;

Secondary

MeasureTime frame
Oswestry disability index (ODI);Timed Up and Go (TUG);Opioid use within 72 hours after surgery;

Countries

China

Contacts

Public Contactliu chaoxu

Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

liu.chaoxu@tjh.timu.edu.cn+86 13477093592

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026