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Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty | Clinical Trials | Clareo Health

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Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

NCT05005260•Mayo Clinic

View on ClinicalTrials.gov

Summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
•Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
•Patients 18 years of age and older
•Able to provide informed consent for him or herself

Exclusion Criteria

•Chronic pain syndromes
•Chronic opioid use (\>1 month) with OME \>5 mg/day OR acute opioid use (\< 1 month) with OME \> 30 mg/day.
•Body mass index (BMI) \> 45 kg/m2
•Severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. \*defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
•Personal or family history of malignant hyperthermia.
•Major systemic medical problems such as:
•* Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) \<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
•* Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
•* Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation \< 93% on room air.
•* History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
+6 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

October 14, 2021

Primary Completion Date

March 18, 2023

Completion Date

March 18, 2023

Last Updated

May 7, 2024

Enrollment

ACTUAL participants

Conditions

Pain, PostoperativeBrachial Plexus Block

Interventions

Bupivacaine HCl

DRUG

Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj

DRUG

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NCT06528288

Fusion of Spine, Lumbar RegionAnesthesia, Local+2 more

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RECRUITINGNA

Opioid Dispenser for Microdiscectomy/Laminectomy

NCT06358040

Opioid UsePain, Postoperative+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

Inclusion Criteria

Exclusion Criteria

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