Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants (NCT03845894) | Clinical Trial Compass
TerminatedPhase 4
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Stopped: feasibility
United States25 participantsStarted 2020-03-03
Plain-language 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 liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.
Who can participate
Age range18 Years
SexALL
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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