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:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT02135120
Eligibility Criteria:
Inclusion Criteria:
* ASA I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks
* Ages 18-80
* BMI ≤ 38 kg/m2
Exclusion Criteria:
* BMI \> 38 kg/m2
* chronic pain disorders
* Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity
* abuse of drugs or alcohol
* Contraindication to a component of multi-modal analgesia
* Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks
* Bilateral TKA surgeries
* History of significant psychiatric conditions that may affect patient assessment
* Pregnancy
* Moderate to severe obstructive sleep apnea.
* Previous adverse reactions resulting from intrathecal opioids (respiratory depression, urinary retention, severe pruritis, severe nausea or vomiting, severe sedation)
* inability to provide informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02135120
Study Brief:
Protocol Section:
NCT02135120