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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT04112550
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 70
* Will undergo one level minimally invasive lumbar fusion surgery
* Primary symptoms are back and/or leg pain
Exclusion Criteria:
* Preoperative chronic renal insufficiency or failure (defined as a serum creatinine more than 2 mg/dl)
* Significant liver disease (cirrhosis or hepatic failure)
* American Society of Anesthesiologists (ASA) physical status IV or V
* Pulmonary disease necessitating home oxygen therapy
* Patients with acute bronchial asthma or hypercarbia
* Patient who has or is suspected of having a paralytic ileus
* Preoperative use of methadone or hydromorphone
* Known hypersensitivity to methadone
* Known hypersensitivity to oxycodone
* Recent history of opioid or alcohol abuse
* Inability to use a PCA device
* Inability to speak English
* Any patient judged by the anesthesia care team to potentially require prolonged postoperative intubation
* Participation in another clinical trial
* Inability of patient to provide study informed consent (including patients who are cognitively impaired)
* Presence of drug interaction between methadone/oxycodone and patient's regular or PRN medications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04112550
Study Brief:
Protocol Section:
NCT04112550