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临床试验/NCT07643883
NCT07643883已完成不适用

Comparison of the Effectiveness of IPACK Block Versus Adductor Magnus Muscle Plane Block When Combined With Adductor Canal Block in Total Knee Arthroplasty Surgery

Ataturk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1

研究概览

简要总结

Total knee arthroplasty (TKA) is among the most frequently performed surgical procedures for degenerative joint diseases, including advanced knee osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. More than 700,000 TKA procedures are performed annually in the United States alone since 2012, with projections estimating a 143% increase by 2050. A significant proportion of patients experience moderate to severe postoperative pain following the procedure, adversely affecting early mobilization, adherence to rehabilitation programs, and ultimately functional recovery .

Femoral nerve block (FNB) was historically the cornerstone of TKA analgesia; however, concerns about quadriceps weakness and associated fall risk led to its replacement by more motor-sparing alternatives . Adductor canal block (ACB) has since become the standard approach, providing analgesia equivalent to FNB while significantly preserving quadriceps strength . Nevertheless, ACB does not adequately cover the posterior capsule and popliteal plexus terminals; consequently, 60-80% of TKA patients report significant posterior knee pain that cannot be sufficiently managed by ACB alone .

To address this limitation, several posterior knee analgesia techniques have been described. The IPACK (Interspace between Popliteal Artery and Capsule of the Knee) block targets genicular nerve branches and popliteal plexus terminals by injecting local anesthetic between the popliteal artery and the posterior knee capsule, largely sparing the main motor trunks and providing selective posterior analgesia . The adductor magnus muscle plane (AMM) block is a relatively novel interfascial plane block technique applicable in the supine position simultaneously with ACB. By injecting local anesthetic into the fascial plane along the posterior surface of the adductor magnus muscle, the AMM block aims to spread to the popliteal plexus and posterior capsular branches, potentially mimicking a sciatic nerve block effect . A key advantage of the AMM block is its applicability without patient repositioning during the same session as ACB.

The primary objective of this prospective randomized trial was to compare the effects of IPACK and AMM blocks-both added to ACB-on postoperative opioid consumption in patients undergoing TKA. Secondary objectives included evaluating the impact of each technique on postoperative pain scores, mobilization time, functional recovery, and motor function

详细描述

Study Design and Ethical Approval This prospective, randomized, parallel-group trial was approved by the Ethics Committee of Atatürk University Faculty of Medicine (Decision No. 5, Meeting No. 7, dated October 26, 2023). Written informed consent was obtained from all participants before enrollment.

Patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III scheduled for primary total knee arthroplasty (TKA) were eligible. Exclusion criteria included hepatic, renal, or advanced cardiac insufficiency; neuropathic pain; use of analgesics within 24 hours before surgery; coagulopathy or anticoagulant therapy; advanced cardiovascular disease; allergy to study medications; inability to cooperate; chronic opioid use; and previous lumbar instrumentation.

Of 90 patients assessed for eligibility, 30 were excluded because of chronic renal failure (n = 3), chronic opioid use (n = 5), anticoagulant therapy (n = 8), inability to cooperate (n = 10), or L2-L4 vertebral instrumentation (n = 4). Sixty patients were included and randomized equally into two groups: IPACK (n = 30) and AMM (n = 30).

Randomization and Blinding Participants were randomized in a 1:1 ratio using a computer-generated randomization sequence one hour before surgery. Allocation assignments were concealed in sealed opaque envelopes and delivered to the operating room technician responsible for preparing the intervention.

The anesthesiologist performing the regional block could not be blinded because of the procedural differences. However, patients, surgeons, and the investigator responsible for postoperative outcome assessment were blinded to group allocation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

入选标准

  • Anesthesiologists (ASA) physical status I-II-III
  • Total Knee Arthroplasty Surgery

排除标准

  • cardiovascular disease,
  • hepatic dysfunction,
  • coagulopathy or current use of anticoagulant therapy,
  • inability to cooperate,
  • known allergy to any of the study medications,
  • refusal to participate in the study

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Murat Yayik

Associate Professor Dr. Ahmet Murat YAYIK

Ataturk University

研究点 (1)

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