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LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

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ClinicalTrials.gov Identifier: NCT03887650
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Sposito, MD, Hartford Hospital

Brief Summary:
This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.

Condition or disease Intervention/treatment Phase
Post-operative Pain Total Shoulder Arthroplasty Osteoarthritis of the Shoulder Pain Management Drug: Liposomal Bupivicaine 1.3% Drug: Bupivacaine 0.5% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-center, prospective, randomized controlled cross-sectional study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liposomal Bupivacaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
Drug: Liposomal Bupivicaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block

Active Comparator: Bupivacaine 0.5% with Adjuncts
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Drug: Bupivacaine 0.5%
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Other Names:
  • epinephrine
  • dexamethasone preservative-free




Primary Outcome Measures :
  1. Total opioid consumption for the first three postoperative days (PODs) after TSA, standardized to morphine milligram equivalents (MMEs) [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Time to first opioid medication [ Time Frame: 60 days ]
  2. Pain assessment at post anesthesia care unit (PACU) arrival, PACU discharge, POD #1, POD #2, POD #4, and POD #60 [ Time Frame: 60 days ]
    using questions from the Modified Brief Pain Inventory (MBPI)

  3. Hospital length-of-stay [ Time Frame: 60 days ]
  4. Assessment of patient overall satisfaction with pain control [ Time Frame: 60 days ]
    on a scale from 0 = very dissatisfied to 10 = very satisfied.

  5. Incidence of distress from block numbness [ Time Frame: 60 days ]
    on a scale of 0 to 10 with 0 = not at all and 10 = very much (adapted from the Overall Benefit of Analgesia Score)

  6. Duration of sensory and motor nerve block [ Time Frame: 3 days ]
  7. Notation of adverse postoperative events or block complications up to 60 days after surgery including: [ Time Frame: 60 days ]
    • Postoperative nausea/vomiting (PONV), as defined by non-prophylactic administration of antiemetics during hospital stay within 24 hours post-operation
    • Local anesthetic systemic toxicity (LAST) as defined by any treatment for this condition during hospital admission
    • Postoperative neurologic symptoms (PONS) as defined as sensory or motor dysfunction in appropriate anatomic distribution of block present at > 4 days post-surgery
    • Postoperative ED visit or readmission due to uncontrolled pain within 60 postoperative days
    • Bleeding/hematoma at the site of local anesthetic injection that develops prior to discharge from the hospital
    • Hospital readmission within 30 days from discharge



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age >18 years;
  • Lack of language barrier;
  • Informed consent obtained;
  • Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon;
  • American Society of Anesthesiology (ASA) physical status score I- III

Exclusion Criteria:

  • Presence of a language barrier;
  • Inability to complete telephone and/or paper questionnaire;
  • Lack of consent;
  • Allergy to local anesthetic;
  • Chronic pain syndrome and/or preoperative opioid use > 50 MME per day (including extended-release formulations and methadone);
  • Preoperative consultation to chronic pain service;
  • History of (<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men);
  • Baseline peripheral neuropathy of the brachial plexus;
  • Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site;
  • Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy;
  • Weight < 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V;
  • Revision arthroplasty;
  • Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block;
  • Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887650


Contacts
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Contact: Bethany Samperi 860-972-5978 bethany.samperi@hhchealth.org
Contact: Carla Maffeo-Mitchell, MD Carla.Maffeo-Mitchell@hhchealth.org

Locations
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United States, Connecticut
The Bone and Joint Institute at Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Jennifer Sposito, MD         
Sponsors and Collaborators
Hartford Hospital
Investigators
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Principal Investigator: Jennifer Sposito, MD Hartford Hospital

Publications:

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Responsible Party: Jennifer Sposito, MD, Principal Investigator, Hartford Hospital
ClinicalTrials.gov Identifier: NCT03887650     History of Changes
Other Study ID Numbers: HHC-2018-0231
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jennifer Sposito, MD, Hartford Hospital:
Brachial Plexus
Liposomal Bupivacaine
Dexamethasone
Interscalene
Bupivacaine
Shoulder Arthroplasty
Regional anesthesia
Exparel
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants