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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT02740127
Eligibility Criteria:
Inclusion Criteria:
1. Patients that consent to participate.
2. Patients undergoing penile prosthesis surgery.
3. Patients that are male.
4. Patients that are 18 years of age or older.
Exclusion Criteria:
1. Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs.
2. Patients with a BMI \> 40.
3. Patients with chronic pain syndromes.
4. Patients with hypersensitivity to Ropivacaine/amide-type anesthetics.
5. Prior surgery of the sacrum.
6. Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames: i) Low molecular weight heparin less than 36 hours prior to surgery. ii) Coumadin less than 5 days prior to surgery. iii) Plavix and NSAIDs less than 7 days prior to surgery.
7. Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery
8. Patients on Celebrex less than 24 hours prior to surgery
9. Patients taking more than 81 mg of Aspirin daily
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02740127
Study Brief:
Protocol Section:
NCT02740127