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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT01125059
Eligibility Criteria:
Inclusion Criteria:
* ASA physical status I, II, and III, male and non-pregnant female
* English-speaking patients
* Ages 18-75 years
* Undergoing elective one or two level posterior lumbar interbody fusion
Exclusion Criteria:
* Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.
* Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).
* history of substance abuse at any time in the past
* known QT prolongation
* Non-elective operations (i.e., cancer or trauma)
* severe hepatic impairment (serum albumin \< 3.0 g/dL in the presence of a history of liver disease)
* pregnancy
* inability to operate a patient-controlled analgesia device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01125059
Study Brief:
Protocol Section:
NCT01125059