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A prospective randomized controlled trial of local use of glucocorticoids in anterior cervical surgery to improve early postoperative nerve root symptoms

A prospective randomized controlled trial of local use of glucocorticoids in anterior cervical surgery to improve early postoperative nerve root symptoms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051807
Enrollment
Unknown
Registered
2021-10-05
Start date
2021-10-10
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Cervical degenerative disease

Interventions

Group A:Intraoperative local administration of dexamethasone + intravenous administration of physiological saline
Group B:Intravenous administration of dexamethasone + intraoperative local administration of physiological saline
Group C:Intraoperative local and postoperative intravenous administration of physiological saline

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Patients diagnosed with cervical spondylotic radiculopathy based on clinical symptoms, signs, and imaging findings; 3. After standardized conservative treatment, the symptoms are ineffective or the symptoms are progressively aggravated, which affects daily life and work, and requires anterior decompression surgery; 4. The operative segment is located between C3/4-C6/7; 5. NDI score greater than or equal to 30%; 6. Be able to fully comply with this agreement psychologically and physically, and cooperate with the scheduled treatment plan, fill in the form, and cooperate with follow-up visits; 7. After the patient signs the informed consent, it means that the patient has known and agreed to carry out the relevant aspects of this study.

Exclusion criteria

Exclusion criteria: 1. There is a history of cervical spine surgery and bone fusion of adjacent segments. 2. Ossification of the posterior longitudinal ligament or cervical spinal stenosis, spinal fracture, severe osteoporosis or a history of bone metabolic disease. 3. Local infection and ulceration of neck skin, systemic inflammatory disease, uncontrolled diabetes, malignant tumor, active hepatitis, etc. 4. Known to suffer from infectious diseases such as AIDS, syphilis, etc. 5. Suffering from autoimmune disease. 6. Received daily immunosuppressive therapy for more than 1 month in the past 12 months. 7. Hypersensitivity to implant materials (PPEK or titanium alloys) or experimental drugs. 8. Severe obesity, history of drug abuse. 9. Those who have a pregnancy plan during pregnancy or research. 10. Participating in other studies that may affect the results of this study.

Design outcomes

Primary

MeasureTime frame
Dosage of analgesic drugs used;

Secondary

MeasureTime frame
Therapeutic Index of the Japanese Orthopaedic Association;Visual Analogue Scale for pain;Cervical Spine Disability Index;Health Status Survey Short Form;Dysphagia classification;rusion rate;

Countries

China

Contacts

Public ContactLiu Hao

West China Hospital, Sichuan University

dr_liuhao6304@126.com+86 189 8060 1369

Outcome results

None listed

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