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



Status:Not yet recruiting
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:March 2019
End Date:April 2020
Contact:Doug Jaffe, DO
Email:jjaffe@wakehealth.edu
Phone:336-716-5855

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Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Shoulder Arthroscopy

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 shoulder arthroscopy.

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 shoulder arthroscopy 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.

Inclusion Criteria:

- All patients undergoing shoulder arthroscopy

- 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

- Systemic glucocorticoids, gabapentin, pregabalin, or duloxetine within 3 days of study

- 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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Doug Jaffe, DO
Phone: 336-716-7194
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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