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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2022-06-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Shoulder Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Liposomal Bupivacaine Interscalene brachial plexus (ISB)

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)

Bupivacaine with adjuvants ISB

Group Type ACTIVE_COMPARATOR

Bupivacaine with adjuvants

Intervention Type DRUG

Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Interventions

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Liposomal bupivacaine

Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)

Intervention Type DRUG

Bupivacaine with adjuvants

Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes