Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canalf and iPACK Blocks in Total Knee Arthroplasty

Официальное название

Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty

Обзор

The purpose of this research study is to compare two different combinations of anesthetic medications to see which works the best in providing the longest lasting pain relief for total knee arthroplasty surgery. The drugs being used are liposomal bupivacaine compared to a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Pain scores will be collected at different intervals during study participation.

Подробное описание

This double-blinded prospective randomized control trial will evaluate analgesia following total knee arthroplasty for patients who receive an adductor canal block and infiltration between the popliteal artery and condyles of the knee (iPACK) block utilizing bupivacaine with the adjuvants clonidine, epinephrine, buprenorphine and dexamethasone (BPV-CEBD), as compared to patients who receive liposomal bupivacaine (LB) for both blocks.

All patients will receive a spinal anesthetic with ropivacaine (17.5 mg) and fentanyl (10 mcg), and an adductor canal and iPACK block for analgesia. Patients randomized to the LB group will receive 10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of LB into both the adductor canal and iPACK blocks (total of 40 ml). The BPV-CEBD group will receive a 20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone - which will be used in both the adductor canal block and iPACK block (total of 40 ml).

On post-operative day (POD) 0, rest and movement pain scores will be collected at 4 hours and 8 hours with time "zero" being the time of the final block placement. On POD 1 and 2, questionnaires will be collected for pain scores at 0700, 1200 and 1700. Participants will be called once daily on days 3 through 7 to collect remaining secondary data, including sleep score, quality of recovery, worst daily pain score, and patient satisfaction (POD 7 only).

Вмешательства

• Препарат Liposomal Bupivacaine
  10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of liposomal bupivacaine into both the adductor canal and iPACK blocks (total of 40 ml)
• Препарат Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination
  20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone which will be used in both the adductor canal block and iPACK block (total of 40 ml)

Первичные конечные точки

• Pain Score with Movement [Срок оценки: Baseline]
• Pain Score with Movement [Срок оценки: Hour 4 post final block placement]
• Pain Score with Movement [Срок оценки: Hour 8 post final block placement]

Вторичные конечные точки (12)

• Pain Score with Rest [Срок оценки: Hour 48 post final block placement]
• Pain Score with Rest [Срок оценки: Hour 72 post final block placement]
• Pain Score with Movement [Срок оценки: Hour 72 post final block placement]
• Highest Daily Pain Score [Срок оценки: Postop Days 3, 4, 5, 6, 7]
• Cumulative Opioid Consumption [Срок оценки: Hour 48 post final block placement]
• Cumulative Opioid Consumption [Срок оценки: Hour 72 post final block placement]
• Quality of Recovery-15 Patient Survey [Срок оценки: Postop Days 3, 4, 5, 6, 7]
• Distance Walked [Срок оценки: 24 hours]
• PROMIS Sleep Disturbance Survey [Срок оценки: Postop Days 3, 4, 5, 6, 7]
• Patient Satisfaction [Срок оценки: Postop Day 7]
• Incidence of Postoperative Nausea [Срок оценки: Up to Postop Day 7]
• Incidence of Postoperative Vomiting [Срок оценки: Up to Postop Day 7]

Критерии участия

Критерии включения

• 18-80 years of age
• Receiving primary total knee arthroplasty
• Patients receiving a spinal anesthetic with ropivacaine and fentanyl
• American Society of Anesthesiology (ASA) category 1 to 3

Критерии исключения

• Revision of Total Knee Arthroplasty
• Opioid use in the prior 6 months > 40 mg oxycodone equivalents per day or long-acting opioids as determined by the Prescription Drug Monitoring Program (PDMP)
• Patients planned to receive general anesthesia
• Patients planned to receive a spinal other than ropivacaine
• History of peripheral neuropathy
• Poorly controlled diabetes (Hgb A1C >8)
• Allergies or contraindications to study medications: acetaminophen, celecoxib (including sulfa), methocarbamol, midazolam, fentanyl, bupivacaine, dexamethasone, acetaminophen, buprenorphine, NSAIDs, clonidine, epinephrine, and liposomal bupivacaine.
• Unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist — Winston-Salem

Идентификаторы

NCT: NCT07097493 · IRB00133197

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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