Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02202369
Eligibility Criteria:
Inclusion Criteria:
1. Subjects undergoing a single level lumbar decompression and fusion
2. \> 18 years of age and \< 70 years of age
3. The subject is willing and able to understand, sign and date the study specific patient informed consent and HIPAA authorization to volunteer participation in the study
Exclusion Criteria:
1. Patients with liver disease (documented liver function test abnormality)
2. Patients with renal disease (documented glomerular filtration rate \< 60mL/min/1.73m2)
3. Patients with a baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day.
4. Patients with active alcohol dependence
5. Patients with active illicit drug dependence
6. Patients \< 18 years of age and \>70 years of age
7. Patients allergic to any medication given in either arm (list medications)
8. Patients who have a seizure disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02202369
Study Brief:
Protocol Section:
NCT02202369