Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Change in Postoperative Knee Pain Score
研究概览
简要总结
The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral 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 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 bilateral total knee arthroplasty (TKA).
The primary objective of this 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 bilateral 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). An anticipated 66 participants who are scheduled for primary, elective bilateral TKA will be enrolled.
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
- Single (Participant)
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, bilateral 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
B-LB in left knee and B-DEX-MPA in right knee
Participants in this arm will receive B-LB in their left knee and B-DEX-MPA in their right knee.
Nerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
Nerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
干预措施: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (Drug)
B-LB in right knee and B-DEX-MPA in left knee
Participants in this arm will receive B-LB in their right knee and B-DEX-MPA in their left knee.
Nerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
Nerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
干预措施: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (Drug)
B-LB in left knee and B-DEX-MPA in right knee
Participants in this arm will receive B-LB in their left knee and B-DEX-MPA in their right knee.
Nerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
Nerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
干预措施: Bupivacaine-Liposomal Bupivacaine (Drug)
B-LB in right knee and B-DEX-MPA in left knee
Participants in this arm will receive B-LB in their right knee and B-DEX-MPA in their left knee.
Nerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
Nerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
干预措施: Bupivacaine-Liposomal Bupivacaine (Drug)
结局指标
主要结局
Change in 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).
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
次要结局
- Average Postoperative Knee Pain Score(Day 7)
- Worst and best pain score(Day 1, Day 2 and 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)
- Persistent opioid use using Yale Postoperative Recovery Scale(Day 7, 6 weeks and 3 months)
- 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 Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10(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 glucose(baseline, day 0, day 1 and day 2)
- Change in white blood cell count (WBC)(baseline, day 0, day 1 and day 2)