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Completed

NCT Number: NCT03887650

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

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.

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Key information

Conditions

Post-operative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis of the Shoulder Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Total Shoulder Arthroplasty

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Bone and Joint Institute at Hartford Hospital

Hartford, Connecticut, 06102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal Bupivicaine 1.3%

Drug

10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block

Bupivacaine 0.5%

Drug

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 outcomes

  1. Total Opioid Consumption

    Time frame: Up to 120 postoperative hours

    Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)

Secondary outcomes

  1. Time to First Opioid Medication

    Time frame: from the time of the block injection until discharge, assessed up to 72 postoperative hours.

    From block time to the first dose of opioids given, measured in hours.

  2. Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours

    Time frame: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60

    Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.

  3. Hospital Length-of-stay

    Time frame: From the date of admission until discharge, assessed up to 72 hours.

    From the date and time of admission to the date and time of discharge, Measured in hours.

  4. Assessment of Patient Overall Satisfaction With Pain Control

    Time frame: POD4 - 60 days

    Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.

  5. Incidence of Distress From Block Numbness

    Time frame: At PACU and Postoperative day 2

    On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.

  6. Duration of Sensory Nerve Block

    Time frame: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60

    Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.

  7. Day of the Final Opioids Used

    Time frame: 0-96 postoperative hours

    The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.

  8. Motor Recovery

    Time frame: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.

    The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5):

    0= No detectable muscle contraction (visible or palpation)

    • Detectable contraction (visible or palpation), but no movement achieved
    • Limb movement achieved, but unable to move against gravity
    • Limb movement against the resistance of gravity
    • Limb movement against gravity and external resistance
    • Normal strength

    The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data.

Other outcomes

  1. Total Amount of Opioid Consumed During the Indicated Time Periods

    Time frame: 0-24, 24-48, 48-72, and 72-120 postoperative hours.

    Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2019
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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