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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT03845894
Eligibility Criteria:
Inclusion Criteria:
* All patients undergoing total shoulder arthroplasty (not a reverse)
* Age ≥ 18 years
* Ability to understand and the willingness to sign an IRB-approved informed consent document.
* ASA patient status I-III patients
* Weight Greater than or equal to 50 kg
Exclusion Criteria:
* Contraindications to an interscalene block or phrenic blockade
* Infection at injection site
* Pre-existing neurological dysfunction affecting the operative extremity
* Chronic pain diagnosis or opioid use \>40mg oxycodone daily equivalents or use of long-acting opioids
* BMI \>40
* Uncontrolled diabetes (A1c \>8.0)
* Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery
* Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)
* Patients who are wards of the state
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
* Patients with moderate-severe hepatic or renal impairment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03845894
Study Brief:
Protocol Section:
NCT03845894