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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT06639503
Eligibility Criteria:
Inclusion Criteria:
• Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture
Exclusion Criteria:
* Subjects younger than 18
* Polytraumatized Subjects
* Subjects with pathologic fractures
* Subjects with tibial plateau fractures treated nonoperatively
* Subjects with tibial plateau fractures treated operatively but with re-operations at the same site
* Subjects with open fractures
* Subjects with fracture-dislocations
* Subjects with active or history of anxiety
* Subjects with visual analog scale anxiety score ≥ 7 measured preoperatively
* Subjects with chronic pain syndromes
* Subjects with chronic opioid use
* Subjects with illicit drug use disorder
* Subjects with alcohol abuse disorder
* Subjects with kidney disease precluding use of ketorolac
* Subjects with liver disease precluding the use of acetaminophen
* Subjects with allergy to acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), opiates or local anesthesia
* Subjects with inability to provide a visual analog scale score postoperatively
* Subjects with contraindications to receiving peripheral nerve blocks, including relevant neurologic deficits, active infection at sites of injections - re-operation at the same site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06639503
Study Brief:
Protocol Section:
NCT06639503