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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT03115151
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects aged 18 years or older
* Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels
Exclusion Criteria:
* Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
* Immunocompromised subject
* Coagulopathy
* Severe liver and renal dysfunction
* Preoperative neurological deficits
* The dura damage during surgery
* Inability to follow directions or comprehend the English language.
* Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
* Prisoners.
* Patient refusal to provide informed consent.
* Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid (fentanyl) allergy if patient assigned epidural analgesia.
* Hydromorphone allergy if patient assigned IV PCA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03115151
Study Brief:
Protocol Section:
NCT03115151