Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study medication mixture for nerve blocks for each study group will be prepared by an unblinded block nurse who will not be involved in block procedure or subsequent assessments. The patients, and the clinical team including the investigators who will perform the nerve blocks and assessors for subsequent patient follow ups will remain blinded to the group assignment throughout the study. Unblinding will occur after the 3-month follow-up is complete for the last enrolled patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
排除标准
- •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
研究组 & 干预措施
Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)
Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with 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.
干预措施: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (Drug)
Bupivacaine-Liposomal Bupivacaine (B-LB)
Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with 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 Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block.
干预措施: Bupivacaine-Liposomal Bupivacaine (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: From anesthesia end time to discharge time, up to 48 hours
In-hospital postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored up to 48-hour between anesthesia end time and discharge time
Postoperative Knee Pain Score
时间窗: Day 1 and Day 2
Average postoperative knee pain scores for the first two postoperative days using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).
次要结局
- Persistent opioid use using NarX(6 weeks and 3 months)
- Change in Quality of Recovery 40 questionnaire(Day 1, 2 and 7)
- Prosthetic joint range of motion(baseline, day 0, day 1 and day 2)
- Change in glucose(baseline, day 0, day 1 and day 2)
- Worst and best pain score(Day 1, Day 2 and Day 7)
- Average Postoperative Knee Pain Score(Day 7)
- Change in functional pain using Brief Pain Inventory (BPI)(baseline, 6 weeks and 3 months)
- Change in neuropathic pain using PainDetect(baseline, 6 weeks and 3 months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10(6 weeks and 3 months)
- Persistent opioid use using Yale Postoperative Recovery Scale(Day 7, 6 weeks and 3 months)
- Change in knee functional status using Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)(6 weeks and 3 months)
- Length of stay(from the start of the surgery to discharge from hospital, up to 48 hours)
- Change in white blood cell count (WBC)(baseline, day 0, day 1 and day 2)
- Absolute value of Interleukin 1 beta (IL-1b)(day 1)