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A Randomized Controlled Trial of Dexamethasone-Loaded Bovine Collagen–Gelatin Hydrogel for Postoperative Pain After Lumbar Spine Surgery

A Randomized Controlled Trial of Dexamethasone-Loaded Bovine Collagen–Gelatin Hydrogel for Postoperative Pain After Lumbar Spine Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116803
Enrollment
Unknown
Registered
2026-01-15
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Lumbar spinal stenosis and lumbar disc herniation

Interventions

Intervention group:Local application of bovine collagen–gelatin hydrogel loaded with dexamethasone (10 mg) at the surgical site after surgery.
Control group:Local application of bovine collagen–gelatin hydrogel loaded with normal saline at the surgical site after surgery.

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of lumbar spinal stenosis or lumbar disc herniation. 2. Failure of conservative treatment and scheduled for lumbar fusion surgery or lumbar discectomy. 3. Provision of written informed consent. 4. Single-level surgery. 5. No other conditions known to cause low back and/or leg pain.

Exclusion criteria

Exclusion criteria: 1. Extremely low pain threshold or psychological instability resulting in inability to comply with the study procedures. 2. Known allergy to the intraoperative study drug mixture. 3. Pregnancy. 4. History of lumbar fusion surgery. 5. Age < 18 years. 6. Non-degenerative etiologies, such as spinal trauma or spinal tumors.

Design outcomes

Primary

MeasureTime frame
VAS score (Visual Analog Scale score);

Secondary

MeasureTime frame
ODI score (Oswestry Disability Index score);Lumbar JOA score (Japanese Orthopaedic Association score for the lumbar spine);Use of rescue analgesics (rescue pain medication);

Countries

China

Contacts

Public ContactXinyu Liu

Qilu Hospital of Shandong University

newyuliu@163.com+86 135 7377 2976

Outcome results

None listed

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