LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887650
• Other study ID #: HHC-2018-0231
• Status: Completed
• Phase: Phase 4
• Start date: March 11, 2019
• Est. completion date: March 8, 2022

Study information

• Verified date: September 2023
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 8, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis of the Shoulder
• Pain Management
• Pain, Postoperative
• Post-operative Pain
• Total Shoulder Arthroplasty

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The Bone and Joint Institute at Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Amount of Opioid Consumed During the Indicated Time Periods	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.	0-24, 24-48, 48-72, and 72-120 postoperative hours.
Primary	Total Opioid Consumption	Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)	Up to 120 postoperative hours
Secondary	Time to First Opioid Medication	From block time to the first dose of opioids given, measured in hours.	from the time of the block injection until discharge, assessed up to 72 postoperative hours.
Secondary	Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours	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.	24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Secondary	Hospital Length-of-stay	From the date and time of admission to the date and time of discharge, Measured in hours.	From the date of admission until discharge, assessed up to 72 hours.
Secondary	Assessment of Patient Overall Satisfaction With Pain Control	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.	POD4 - 60 days
Secondary	Incidence of Distress From Block Numbness	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.	At PACU and Postoperative day 2
Secondary	Duration of Sensory Nerve Block	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.	Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
Secondary	Day of the Final Opioids Used	The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.	0-96 postoperative hours
Secondary	Motor Recovery	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.	PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.