Treatment of pain associated with total knee arthroplasty with sustained-release liposomal anesthetic compositions
Inventors
Assignees
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Publication Number
US-12226610-B2
Publication Date
2025-02-18
Expiration Date
Abstract
In some embodiments provided herein are methods of administering an adductor canal block in a patient, wherein the methods include: (a) selecting an entry point of an injection needle in a leg of the patient; (b) inserting the injection needle into the leg of the patient at the entry point; (c) identifying a first nerve in the leg of the patient; (d) administering to the first nerve saline and a pharmaceutical composition; (e) identifying a second nerve in the leg of the patient; (f) administering to the second nerve saline and the pharmaceutical composition; wherein the first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, and wherein the first nerve is not the second nerve, and wherein the pharmaceutical composition comprises multivesicular liposomes.
Core Innovation
The disclosed invention relates to administering regional analgesia by adductor canal block to a patient using an ultrasound transducer to select an entry point of an injection needle in a leg and to insert the needle at the entry point. A first nerve in the adductor canal is identified and administered saline and a pharmaceutical composition, and a second nerve in the adductor canal is separately identified and administered saline and the pharmaceutical composition. The first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, where the first nerve is not the second nerve.
The pharmaceutical composition comprises multivesicular liposomes comprising at least one amphipathic lipid, at least one neutral lipid, and bupivacaine phosphate, wherein the bupivacaine phosphate is encapsulated within the multivesicular liposome. The methods specify a total amount of the pharmaceutical composition, including 133 mg, and deliver multivesicular liposome-encapsulated bupivacaine phosphate to selected nerves.
The disclosed invention further includes methods directed to reducing opioid consumption and increasing the amount of time before opioid medication is administered, using ultrasound-guided selection of needle entry points and nerve identification within the adductor canal. Optional refinements include additional ultrasound-guided nerve-related localization and an additional local anesthetic administration in a defined space between the popliteal artery and the posterior capsule of the knee.
Claims Coverage
The independent claims provide coverage for four method categories: ultrasound-guided adductor canal block using separate delivery to first and second nerves with saline plus multivesicular liposome-encapsulated bupivacaine phosphate; reducing opioid consumption over at least 24 hours by the same nerve-targeted adductor canal administration; increasing the amount of time before opioid medication is administered by nerve-targeted adductor canal multivesicular liposome administration; and administration with a specified total dose including 133 mg. The inventive features center on ultrasound-guided adductor canal nerve targeting and a specific MVL bupivacaine phosphate composition.
Ultrasound-selected needle entry and two adductor canal nerve targeting with separate saline plus MVL-bupivacaine phosphate administration
Selecting an entry point of an injection needle in a leg by ultrasound transducer; inserting the injection needle at the entry point; identifying a first nerve in the adductor canal and administering saline and a pharmaceutical composition to the first nerve; identifying a second nerve in the adductor canal and administering saline and the pharmaceutical composition to the second nerve; wherein the first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, and wherein the first nerve is not the second nerve; and wherein the pharmaceutical composition comprises multivesicular liposomes comprising at least one amphipathic lipid, at least one neutral lipid, and bupivacaine phosphate, wherein the bupivacaine phosphate is encapsulated within the multivesicular liposome.
Ultrasound-guided opioid consumption reduction using adductor canal nerve targeting with MVL-bupivacaine phosphate
Selecting an entry point of an injection needle in a leg by ultrasound transducer; identifying a first nerve in the adductor canal and administering saline and about 10 mL of a pharmaceutical composition to the first nerve; identifying a second nerve in the adductor canal and administering saline and about 10 mL of the pharmaceutical composition to the second nerve; wherein the first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, and wherein the first nerve is not the second nerve; wherein the pharmaceutical composition comprises multivesicular liposomes comprising at least one amphipathic lipid, at least one neutral lipid, and bupivacaine phosphate, wherein the bupivacaine phosphate is encapsulated within the multivesicular liposome; thereby reducing opioid consumption over a period of at least 24 hours.
Ultrasound-guided adductor canal block with MVL-bupivacaine phosphate for first and second nerves at a total 133 mg dose
Selecting an entry point of an injection needle in a leg of the patient; inserting the injection needle at the entry point; identifying a first nerve in the adductor canal and administering to the first nerve a pharmaceutical composition; identifying a second nerve in the adductor canal and administering to the second nerve the pharmaceutical composition wherein 133 mg of the pharmaceutical composition is administered in total; wherein the first nerve and second nerve are selected from the group consisting of the nerve to vastus medialis (NVM) and the saphenous nerve, and wherein the first nerve is not the second nerve; and wherein the pharmaceutical composition comprises multivesicular liposomes comprising at least one amphipathic lipid, at least one neutral lipid, and bupivacaine phosphate, wherein the bupivacaine phosphate is encapsulated within the multivesicular liposome; thereby administering the adductor canal block to the patient.
Ultrasound-guided MVL-bupivacaine phosphate delivery to NVM and saphenous nerve to increase time before opioid medication
Selecting an entry point of an injection needle in a leg of a patient by ultrasound transducer; advancing a needle tip within a region between a vastus medialis muscle and a sartorius muscle along a trajectory that extends between the entry point and a superficial femoral artery; identifying a nerve to vastus medialis (NVM) and administering about 10 mL of a multivesicular liposome pharmaceutical composition; identifying a saphenous nerve and administering about 10 mL of a multivesicular liposome pharmaceutical composition to the saphenous nerve; wherein 133 mg of the pharmaceutical composition is administered in total; and wherein the pharmaceutical composition comprises bupivacaine or a salt thereof, phosphoric acid, a lipid component comprising at least one amphipathic lipid and at least one neutral lipid lacking a hydrophilic head group, and a cholesterol and/or a plant sterol.
Across the independent claims, the inventive core is ultrasound-guided adductor canal block delivery that separately targets a first and second nerve selected from NVM and the saphenous nerve, with saline and an MVL pharmaceutical composition in which bupivacaine phosphate is encapsulated. The claims also recite specified total dosing, including 133 mg, and method outcomes of reducing opioid consumption or increasing the amount of time before opioid medication is administered.
Stated Advantages
Reduced pain and opioid consumption over a period of at least 24 hours.
Delayed time to first opioid.
Increased amount of time before opioid medication is administered to the patient.
Prolonged sensory block duration.
Altered pharmacokinetics (early/late Cmax) as described in the document’s clinical trial outcomes.
Safety and tolerability outcomes including reported TEAEs and SAEs.
Documented Applications
Ultrasound-guided adductor canal block administration for postoperative pain in primary unilateral total knee arthroplasty (TKA).
Use in a Phase 3 randomized double-blind trial comparing EXP133 (MVL + bupivacaine HCl) versus bupivacaine HCl alone for postoperative pain and opioid-related outcomes after TKA.
Methods directed to reducing opioid consumption over a period of at least 24 hours in connection with adductor canal block delivery.
Methods directed to increasing the amount of time before opioid medication is administered in connection with adductor canal block delivery.
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