Liposomal Bupivacaine vs Dexamethasone ISB

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2021-03-19

Brief Summary

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In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

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Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liposomal bupivacaine & standard bupivacaine

Group Type EXPERIMENTAL

Exparel 133 MG Per 10 ML Injection

Intervention Type DRUG

10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)

Standard bupivacaine & dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Interventions

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Exparel 133 MG Per 10 ML Injection

10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)

Intervention Type DRUG

Dexamethasone

15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Intervention Type DRUG

Other Intervention Names

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Liposomal Bupivacaine

Eligibility Criteria

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Inclusion Criteria

* ASA I-III
* Age 18 years or older
* Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion Criteria

* History of allergy to local anesthetic, or one of the study medications
* Pre-existing neurological deficits
* Psychiatric or cognitive disorders that prohibit patients from following study protocol
* History of drug or alcohol abuse
* Chronic opioid use (longer than 3 months)
* Chronic pain syndromes
* Infection at the site of injection
* Patients with severe pulmonary disease
* Herniated cervical disc, cervical myelopathy
* Contraindication for general anesthesia and/or interscalene nerve block
* Pregnancy
* Open shoulder arthrotomies.
* Non English speakers

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No