跳至主要内容
临床试验/NCT07092982
NCT07092982招募中不适用

Comparison of the Effects of Ultrasound-Guided Adductor Canal Block With iPACK (Space Between the Popliteal Artery and the Posterior Knee Capsule) Block Combination and Suprainguinal Fascia Iliaca Block on Postoperative Pain and Stress Response in Patients Undergoing Total Knee Arthroplasty

SB Istanbul Education and Research Hospital2 个研究点 分布在 2 个国家目标入组 52 人开始时间: 2025年8月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
2
主要终点
Cumulative opioid consumption

研究概览

简要总结

Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.

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, Outcomes Assessor)

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

  • Patients undergoing total knee arthroplasty
  • Patients aged 18-75
  • Patients with ASA I-II-III

排除标准

  • Coagulation disorders
  • Allergy to local anesthetics
  • Liver and renal failure
  • Alcohol and drug addiction
  • Cognitive dysfunction that may prevent pain assessment
  • Systemic or needle insertion site infection
  • Analgesic use for more than 3 months
  • Patient refusal to participate in the study/refusal to consent
  • Presence of a hematoma, hernia, neoplasm, etc. in the area where the block will be performed
  • Pre-existing neurological deficit
  • Patients with contraindications to nerve block

研究组 & 干预措施

Ultrasound Guided Fascia Iliaca Block

Active Comparator

Suprainguinal fascia iliaca block was applied to the patients in this group at the end of the operation.

干预措施: Ultrasound Guided Suprainguinal Fascia Iliaca Block (Procedure)

Ultrasound Guided Adductor Canal Block + iPACK Block

Active Comparator

Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation.

干预措施: Ultrasound Guided Adductor Canal Block (Procedure)

Ultrasound Guided Adductor Canal Block + iPACK Block

Active Comparator

Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation.

干预措施: Ultrasound Guided iPACK Block (Procedure)

结局指标

主要结局

Cumulative opioid consumption

时间窗: 24 hours

Tramadol consumption will be recorded for 24 hours.

次要结局

  • Numeric rating scale for pain(Up to 24 hours)
  • Postoperative quadriceps muscle strength(Up to 24 hours)
  • Quality of Recovery 15 (QoR-15)(24 hours)
  • Inflammatory marker levels(Up to 24 hours)
  • Time to first postoperative analgesic requirement(Up to 24 hours)
  • Incidence of postoperative nausea and vomiting(Up to 24 hours)

研究者

发起方
SB Istanbul Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kubilay Ekinci

Anesthesiology and Reanimation Resident

SB Istanbul Education and Research Hospital

研究点 (2)

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