None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 20 to 80 years 2. The patients with degenerative lumbar disease (spinal stenosis, degenerative spondylolisthesis) 3. If the applicant (signable only) or a legal representative has signed the agreement after fully understanding the contents of the trial,
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications (blood coagulation disorder, infection) or epidural injection, or experienced partial anesthetic adverse events 2. Patients with clinically significant impairment of cardiovascular, digestive, respiratory, endocrine, or central nervous system, and those who are at risk for administration of the remedy Ketorolac or fentanyl 3. Patients with past history of drug analgesics (except tramadol) within 2 weeks before scheduled surgery 4. Those who have collagen-vascular or autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus) or who have been treated for malignant tumors within 5 years 5. Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening 6. Pregnant or lactating women 7. Weight less than 45 kg or less than 100 kg 8. Any other person who is considered inappropriate by the medical examiner 9. Those who refused to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric rating scale (NRS) for low back pain measured from the time of exit from recovery room | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of times the pain-control button was pressed from the time of exit from recovery room;Quantity of ketorolac and rescue fentanyl used up to 48 hours after entering the recovery room;The number of nausea and vomiting that require oral antiemetics;Constipation that lasts more than 3 days after surgery;Urinary retension symptom;Likert satisfaction scale scoring;Numeric rating scale (NRS), oswestry disability index(ODI) | — |
Countries
Korea, Republic of
Contacts
Chung-Ang Univerisity Hospital