Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Официальное название

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study

Обзор

The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Подробное описание

This phase 2, double blinded and randomized clinical trial will investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA).

The primary objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing total knee arthroplasty (TKA). The secondary objective of this study is to test the effects of perineural use of B-DEX-MPA vs B-LB on the quality of postoperative recovery as well as surgical outcome and neuropathic pain among patients undergoing unilateral TKA.

This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

This will be a single center study at Yale New Haven Hospital (YNHH) performed at two clinical sites: York St. Campus (York Street, New Haven) and St. Raphael Campus (Chapel Street, New Haven). 250 primary, elective and unilateral TKA patients will be enrolled, and equally randomized (1:1 ratio) to receive peripheral nerve blockade with B- LB or B-DEX-MPA.

Вмешательства

• Препарат Bupivacaine-Liposomal Bupivacaine
  Adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an iPACK block
• Препарат Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate
  Adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block.

Первичные конечные точки

• Postoperative Knee Pain Score [Срок оценки: Day 1 and Day 2]
• Postoperative opioid consumption [Срок оценки: From anesthesia end time to discharge time, up to 48 hours]

Вторичные конечные точки (12)

• Average Postoperative Knee Pain Score [Срок оценки: Day 7]
• Worst and best pain score [Срок оценки: Day 1, Day 2 and Day 7]
• Change in functional pain using Brief Pain Inventory (BPI) [Срок оценки: baseline, 6 weeks and 3 months]
• Change in neuropathic pain using PainDetect [Срок оценки: baseline, 6 weeks and 3 months]
• Persistent opioid use using Yale Postoperative Recovery Scale [Срок оценки: Day 7, 6 weeks and 3 months]
• Persistent opioid use using NarX [Срок оценки: 6 weeks and 3 months]
• Change in Quality of Recovery 40 questionnaire [Срок оценки: Day 1, 2 and 7]
• Prosthetic joint range of motion [Срок оценки: baseline, day 0, day 1 and day 2]
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 [Срок оценки: 6 weeks and 3 months]
• Change in knee functional status using Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) [Срок оценки: 6 weeks and 3 months]
• Length of stay [Срок оценки: from the start of the surgery to discharge from hospital, up to 48 hours]
• Change in glucose [Срок оценки: baseline, day 0, day 1 and day 2]

Критерии участия

Критерии включения

• American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

Критерии исключения

• Refusal of consent
• Pregnancy
• Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically
• Coagulopathy
• Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB
• Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)
• Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >200mg/dl, or HbA1C > 8.0%
• Peripheral Nerve Block site or systemic infection
• Immune compromise (e.g., HIV, chronic glucocorticoid use)
• Severe pre-existing neuropathy
• TKA for indications other than osteoarthritis such as post-traumatic injury or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or bilateral TKA
• Severe hepatic or renal dysfunction (GFR <50 ml/min)
• Actual body weight <60 kg
• Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis

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

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Yale New Haven Hospital Saint Raphael Campus — New Haven
• Yale New Haven Hospital York Street Campus — New Haven

Идентификаторы

NCT: NCT05279092 · 2000031881 · 000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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