NCT06952556招募中4 期
A Randomized, Single-blind, Single-center Study Measuring the Effects of Adductor Canal Block Combined With IPACK Infiltration Compared to Adductor Canal Block Alone on Post-operative Pain and Opioid Consumption in Patients Undergoing HTO/DFO/TTO
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Opioid Utilization for First 24 Hours Post-Surgery
研究概览
简要总结
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 75 years of age
- •Patients undergoing HTO/DFO/TTO.
- •American Society of Anesthesiologists (ASA) I or II
排除标准
- •Patients younger than 18 and older than
- •Patients with multi-ligament injury
- •Patients undergoing concomitant cartilage procedure or ACLR.
- •Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
- •Patients who are allergic to oxycodone;
- •Patients with diagnosed or self-reported cognitive dysfunction;
- •Patients with a history of neurologic disorder that can interfere with pain sensation;
- •Patients with a history of drug or recorded alcohol abuse;
- •Patients who are unable to understand or follow instructions;
- •Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- •Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- •Patients with a BMI over 45;
- •Any patient that the investigators feel cannot comply with all study related procedures;
- •Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
研究组 & 干预措施
Adductor Canal Block (ACB) + IPACK Block
Experimental
Participants receive ACB with IPACK block.
干预措施: ACB (Drug)
Adductor Canal Block (ACB) + IPACK Block
Experimental
Participants receive ACB with IPACK block.
干预措施: IPACK block (Drug)
Isolated Adductor Canal Block
Active Comparator
Participants receive ACB only.
干预措施: ACB (Drug)
结局指标
主要结局
Opioid Utilization for First 24 Hours Post-Surgery
时间窗: Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])
Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oral morphine equivalent.
次要结局
- Length of Stay in PACU(Post-Operation (POD 0 - typically up to 3 hours))
- Patient-Reported Visual Analogue Scale (VAS) Score - Baseline(Baseline)
- Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)(Post-Operation (POD 0 - typically up to 3 hours))
- Patient-Reported VAS Score - Month 6 Follow-Up(Month 6 Post-Operation)
- Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline(Baseline)
- Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline(Baseline)
- Kujala Score / AKPS - Month 6 Follow-Up(Month 6 Post-Operation)
- Tegner Activity Scale (TAS) Score - Month 6 Follow-Up(Month 6 Post-Operation)
- Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)(POD 1)
- Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)(POD 2)
- Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)(POD 3)
- Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)(POD 7)
- KOOS-PS Score - Month 6 Follow-Up(Month 6 Post-Operation)
- Tegner Activity Scale (TAS) Score - Baseline(Baseline)
研究者
研究点 (1)
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