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临床试验/NCT07681622
NCT07681622尚未招募不适用

Migration Rate for Continuous Adductor Canal Block Catheters After Primary Total Knee Arthroplasty Surgery: a Comparison Between the Interfascial Plane Between SArtorious Muscle and FEmoral Artery (ISAFE) and the Out Of Plane Parallel to Saphenous Nerve (OOPS) Techniques: The ISAFE x OOPS Trial

University of Toronto1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
48
试验地点
1
主要终点
Catheter migration

研究概览

简要总结

Continuous adductor canal block (CACB) is becoming increasingly popular for providing postoperative analgesia following knee arthroplasties. These continuous blocks are provided through inserted nerve catheters and effectively extend the duration of analgesia, thereby reducing opioid consumption. This, in turn, helps minimize opioid-related side effects, promotes early ambulation, and supports earlier discharge. However, catheter migration remains a significant concern, as the catheter tip can become displaced from the adductor canal due to movements associated with ambulation or physiotherapy. In this study, the investigators compare the migration rates of two different techniques for CACB catheters insertion: the Interfascial plane between SArtorious muscle and FEmoral artery (ISAFE) and the Out Of Plane parallel to Saphenous nerve (OOPS) techniques. Pain scores and opioid consumption on postoperative day 1 (POD1) will also be assessed as secondary outcomes. The hypothesis is that both techniques will result in similar migration rates of CACB catheter.

详细描述

Joint replacement surgeries are often followed by significant early postoperative pain, necessitating effective pain management with minimal side effect. Over the years, various analgesic modalities have been employed, but each comes with its own limitations. Opioids are a commonly used class of oral and intravenous/intramuscular pain medications that provide excellent analgesic control, yet are associated with side effects, such as nausea, vomiting, sedation, constipation and respiratory depression. Non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used as adjuvants alongside acetaminophen, but use is contraindicated in patients with bleeding disorders, gastric ulcers, or renal or liver impairment.

Peripheral nerve blocks have emerged as a highly effective pain management option with minimal side effects. Historically, femoral nerve blocks were used to control pain after knee replacement surgeries; however, the associated motor block delayed patient mobilization and hospital discharge. In contrast, adductor canal blocks (ACB) have demonstrated effective pain relief without causing important quadriceps weakness. While ACB is generally safer, it can be associated with complications such as vascular puncture, nerve injury, and, in rare cases, local anesthetic systemic toxicity (LAST). The use of ultrasound guidance, along with proper technique, significantly reduces the likelihood of these complications.

One limitation of any single-shot nerve block is the variability in the duration of its effect, depending on the local anesthetic used. CACBs address this issue by providing prolonged length for ACB and longer pain control. However, the insertion of CACB catheters carries similar risks to those of single-shot nerve blocks, in addition to the potential for catheter migration outside the adductor canal, which leads to loss of effectiveness. With proper techniques to increase safety and effectiveness, CACB holds great potential as a mainstay of postoperative analgesia for knee arthroplasty patients.

At Mount Sinai Hospital - Sinai Health System, CACB has become standard practice for knee arthroplasty patients. The catheter tip is placed near the saphenous nerve in the mid-thigh region under ultrasound guidance. The ISAFE (Interfascial plane between the SArtorius muscle and FEmoral artery) approach is used for catheter insertion, which has been shown to reduce catheter dislodgement by 26.3% compared to the conventional technique. Another technique for CACB catheter insertion, named OOPS (Out Of Plane parallel to Saphenous nerve), has demonstrated a lower incidence of catheter migration outside the adductor canal when compared to the conventional insertion technique. In the OOPS technique, the catheter is inserted through an ultrasound guided out-of-plane manner, parallel to the saphenous nerve, ensuring that it remains securely within the adductor canal, reducing the likelihood of dislodgement with patient movement.

SIGNIFICANCE Currently, no published studies directly compare the migration rates of the ISAFE and OOPS techniques for CACB catheter insertion. Effective postoperative analgesia promotes early ambulation, accelerating recovery and potentially reducing hospital stays. Techniques that minimize catheter migration can lead to better outcomes, while inadequate pain control remains a significant factor contributing to prolonged hospital stays. Optimized inserted CACB catheters facilitate same-day discharge and may help reduce healthcare costs.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-pregnant patients older than 18 years of age;
  • Patients undergoing unilateral primary total knee arthroplasty in an inpatient regime;
  • American Society of Anesthesiologist (ASA) physical status Class I - IV patients;
  • With sufficient understanding and co-operation about usage of a perineural catheter for pain management;
  • With body mass index (BMI) under 45;
  • With no history of strong opioid use of more than 30 mg of oral morphine equivalent (OME)/day during the 2 weeks preceding the surgery;
  • No alcohol or drug use disorder history;
  • With no contra-indication for the performance of ACB and IPACK block;
  • With no contra-indication for spinal anesthesia;
  • With no contra-indication for CACB catheter insertion (local site infection, systemic infection, anatomical abnormality);
  • With no contra-indication for the medications to be used accordingly with the study protocol (ropivacaine, lidocaine, mepivacaine, midazolam, fentanyl, propofol, cefazolin, tranexamic acid, dexamethasone, ondansetron, celecoxib, acetaminophen, hydromorphone);
  • Speak and understand the English language;
  • Agree to participate on this study through the signature of the consent form.

排除标准

  • They have a failed spinal anesthesia and needs for a conversion to general anesthesia;
  • The peripheral nerve blocks are not possible to be performed due to technical difficulties;
  • A deviation of the protocol occurs (not follow the standardized postoperative analgesia orders; need an emergency re-operation of the same knee, in less than 24 hours, due to a surgical complication; have an important perioperative complication, leading to abnormal level of conscience);
  • CACB catheter has issues on its function and needs to be removed before the migration assessment
  • Patient decides to withdraw from the study.

结局指标

主要结局

Catheter migration

时间窗: 24 hours

Rate of migration of the catheter tip to outside the adductor canal , verified by ultrasound assessment

次要结局

  • Pain intensity(24 hours)
  • Opioid consumption(24 hours)
  • Number of attempts for catheter insertion(4 hours)
  • Potential complications related to CACB(24 hours)
  • Incidence of sensory block(24 hours)

研究者

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

Hermann dos Santos Fernandes

Dr

University of Toronto

研究点 (1)

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