Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

Wake Forest University (WFU)

Status and phase

Terminated

Phase 4

Conditions

Shoulder Arthroplasty

Treatments

Drug: Liposomal bupivacaine

Drug: Bupivacaine with adjuvants

Study type

Interventional

Funder types

Other

Identifiers

NCT03845894

IRB00055981

Details and patient eligibility

About

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.

Full 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 pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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