Status:
TERMINATED
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Shoulder Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposom...
Detailed Description
The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03845894
Start Date
March 3 2020
End Date
June 25 2022
Last Update
November 13 2023
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157