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 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 1:42 AM
NCT ID:
NCT01550094
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery
* Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively
* ASA status I-IV
* Ability to understand and provide informed consent
Exclusion Criteria:
* True allergy, not sensitivity, to any of the following substances:
Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol
* Pregnancy
* Evidence of infection at or near the proposed needle insertion site
* Unstable or undetermined neurologic disease of the lower extremity
* Chronic pain patients
* Patient refusal or inability to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01550094
Study Brief:
Protocol Section:
NCT01550094