Efficacy of epidural gelatin sponge with dexamethasone and fentanyl after posterior laminectomy and instrument fusion in lumbar degenerative diease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240419004

Enrollment

Registered

2024-04-19

Start date

2023-11-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

posterior decompression and instrument fusion is a major procedure that cause intense postoperative pain. Early postoperative pain lead to delay mobilization and prolong hospital stay , result in recumbent-related morbidity such as deep venous thrombosis and hospital acquired pneumonia . lumbar degenerative spine , gelatin sponge , dexamethasone , fentanyl

Interventions

Dexamethasone 8 mg and Fentanyl 50 mcg was applied to the gelatin sponge. The size of gelatin sponge was adjusted base on the epidural space and placed over the intact dura After spinal surgery ,Norma

Active Comparator Drug,Placebo Comparator No treatment

epidural gelatin sponge with dexamethasone and fentanyl ,epidural gelatin sponge with normal saline

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Lumbar degenerative disease 2. Underwent posterior decompression and instrument fusion 1-2 level

Exclusion criteria

Exclusion criteria: 1. Pain related implant complication 2. Other spinal condition : cancer , rheumatoid , neurologic disorder 3. Surgical site infection 4. Previous lumbar spinal surgery 5. Drug interaction : macrolide , carbamazepine , phenytoin 6. Pregnant or lactating women 7. Contraindication to Fentanyl administration : hypersensitivity reaction , history of opioid dependence

Design outcomes

Primary

Measure	Time frame
Postoperative pain intensity 6 , 12 , 24 , 48 and 72 hour after surgery Visual analog scale with o is no pain and 10 is extreme pain , the patient is asked to mark their current pain level on the line	—

Secondary

Measure	Time frame
Morphine consumption 6 , 12 , 24 , 48 and 72 hour after surgery . amount of morphine injection after operation (mg),Time to ambulation Hour Duration of ambulation after surgery ,Time of hospital stay Hour Duration of stay in hospital ,Adverse event 6 , 12 , 24 , 48 and 72 hour after surgery nausea and vomiting , dizziness , respiratory distress , wound complication	—

Countries

Thailand

Contacts

Public ContactNuttapol Rujirachotiwat

Department of orthopedics , Police general hospital

Hamnuttapol@gmail.com0619936463

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026