Clinical trial NCT03887650: LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Official title: LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Total Shoulder Arthroplasty
Osteoarthritis of the Shoulder
Pain Management
Keywords: Brachial Plexus
Liposomal Bupivacaine
Dexamethasone
Interscalene
Bupivacaine
Shoulder Arthroplasty
Regional anesthesia
Exparel
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, randomized controlled cross-sectional study
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Total Opioid Consumption
timeFrame: Up to 120 postoperative hours
Secondary outcomes:
measure: Time to First Opioid Medication
timeFrame: from the time of the block injection until discharge, assessed up to 72 postoperative hours.
measure: Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
timeFrame: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
measure: Hospital Length-of-stay
timeFrame: From the date of admission until discharge, assessed up to 72 hours.
measure: Assessment of Patient Overall Satisfaction With Pain Control
timeFrame: POD4 - 60 days
measure: Incidence of Distress From Block Numbness
timeFrame: At PACU and Postoperative day 2
measure: Duration of Sensory Nerve Block
timeFrame: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
measure: Day of the Final Opioids Used
timeFrame: 0-96 postoperative hours
measure: Motor Recovery
timeFrame: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.
Other outcomes:
measure: Total Amount of Opioid Consumed During the Indicated Time Periods
timeFrame: 0-24, 24-48, 48-72, and 72-120 postoperative hours.
Locations:
city: Hartford
country: United States
facility: The Bone and Joint Institute at Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Kevin Finkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
citation: Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
citation: Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a.
citation: Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9.
citation: Rasmussen SB, Saied NN, Bowens C Jr, Mercaldo ND, Schildcrout JS, Malchow RJ. Duration of upper and lower extremity peripheral nerve blockade is prolonged with dexamethasone when added to ropivacaine: a retrospective database analysis. Pain Med. 2013 Aug;14(8):1239-47. doi: 10.1111/pme.12150. Epub 2013 Jun 11.
citation: McLaughlin DC, Cheah JW, Aleshi P, Zhang AL, Ma CB, Feeley BT. Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. J Shoulder Elbow Surg. 2018 Apr;27(4):686-691. doi: 10.1016/j.jse.2017.11.015. Epub 2018 Jan 3.
citation: Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x.
citation: Abildgaard JT, Lonergan KT, Tolan SJ, Kissenberth MJ, Hawkins RJ, Washburn R 3rd, Adams KJ, Long CD, Shealy EC, Motley JR, Tokish JM. Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2017 Jul;26(7):1175-1181. doi: 10.1016/j.jse.2017.03.012. Epub 2017 May 4.
citation: Hannan CV, Albrecht MJ, Petersen SA, Srikumaran U. Liposomal Bupivacaine vs Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):424-430.
citation: Wang K, Zhang HX. Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Oct;46:61-70. doi: 10.1016/j.ijsu.2017.08.569. Epub 2017 Aug 24.
citation: Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3.
citation: Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.