跳至主要内容
临床试验/NCT05313269
NCT05313269已完成不适用

Inter-fascial Plane Between the SArtorius Muscle and FEmoral Artery (ISAFE): a Novel Technique for Adductor Canal Catheter Insertion.

University of Toronto2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月28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
100
试验地点
2
主要终点
Catheter dislodgement

研究概览

简要总结

Total knee arthroplasty (TKA) is a frequent performed surgery. Adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. Continuous adductor canal block (CACB) has been proven superior when compared to single-injection adductor canal block (SACB) for TKA analgesia. However, safety concerns such as intravenous insertion, nerve injury, or catheter displacement must always be considered. The purpose of this study is to evaluate the Inter-fascial Plane between SArtorius Muscle and FEmoral Artery (ISAFE) approach for adductor canal catheter placement, in terms of catheter dislodgment, clinical effectiveness and complications, in comparison with the classical approach, as TKA postoperative analgesia modality. We hypothesize that ISAFE approach can result in a smaller rate of dislodgments in the way that it increases the clinical benefit of CACB.

详细描述

Introduction Total knee arthroplasty (TKA) is an effective treatment for end stage osteoarthritis, with over 75,000 TKA performed in Canada annually (https://www.cihi.ca/en/hip-and-knee-replacements-in-canada-cjrr-annual-report) and an incidence rate of 135 per 100000 of population, among OECD countries, in 2017 (https://www.oecd-ilibrary.org/sites/2fc83b9a-en/index.html?itemId=/content/component/2fc83b9a-en). Historically, TKA has been associated with a significant level of postoperative pain, which can be a barrier to an early discharge. In order to optimize analgesia and minimize opioid consumption and its associated side effects, regional anesthesia techniques traditionally used for TKA include peripheral nerve blocks such as femoral and adductor canal blocks (ACB). These blocks typically provide superior analgesia by anesthetizing peripheral nerves that supply sensory innervation to the surgical site. Specifically, the ACB is of great value as it does not cause the quadriceps weakness motor block that the femoral nerve block provides, thereby facilitating early patient mobilization and discharge. An even newer technique has also emerged called the IPACK (infiltration between the popliteal artery and capsule of the knee), which has been used in some centers to replace sciatic blocks to cover posterior knee pain experienced by many TKA patients, without affecting motor function of the lower leg and foot. Recently, continuous adductor canal blocks (CACB) via an inserted adductor canal catheter (ACC) have started to replace single injection blocks, as they extend the block duration and offer prolonged analgesia. Studies evaluating CACB have it to be superior when compared to single-injection adductor canal block (SACB) for inpatients post-TKA analgesia. Currently at Sinai Health, CACB has become the standard of care for inpatient TKA with all patients routinely being offered this analgesic modality.

Placing a successful ACC is not without risk or technical difficulty. The classic insertion approach involves placing the tip of the ACC near the saphenous nerve in the mid-thigh area. The proximity of the femoral artery (FA) and femoral vein (FV) to the saphenous nerve adds the risk of vascular puncture and intravascular placement of the ACC. Specifically, the FV is deeper and more difficult to visualize as it is compressible, and can be easily punctured if the needle is manipulated in its proximity. Intravenous placement of an ACC will result local anesthetic systemic toxicity (LAST), a potentially lethal albeit very rare complication, and therefore effort should be made to avoid this at all costs. Lastly, a more common obstacle when placing ACC is ensuring that the catheter stays inside the adductor canal. Since the adductor canal itself is very narrow, the catheter tip can easily migrate out of the canal with patient movement and mobilization, resulting in no sensory block and inadequate analgesia. It is not uncommon for patients to initially have well working CACB, but to experience significant rebound pain on postoperative days (POD) 1 or 2 due to catheter dislodgement out of the canal.

In order to address these issues we have developed a novel insertion approach for ACC is inserted into the inter-fascial plane between the Sartorius muscle and femoral artery (ISAFE). In this technique, the needle is inserted into the plane between the sartorius muscle and FA. A catheter is then threaded between the artery and muscle, well away from the FV. This facilitates keeping the needle away from the vein and maintaining more catheter length inside the adductor canal, thereby preventing catheter dislodgement. The insertion angle of the needle is shallower when compared to the classic ACC technique, allowing for better needle visualization, and steering clear of the FV. While the needle is still in close proximity to the FA, this vessel is easier to visualize, more difficult to puncture, and is much less likely to result in LAST.

While the ISAFE technique is an exciting novel approach for ACC insertion, it still requires evaluation in terms of analgesia efficacy and superiority in terms of reducing catheter dislodgement.

Significance There are no published prospective randomized controlled trials that compare insertion techniques for ACC and their respective outcomes in terms of catheter positioning, dislodgement, and safety. As TKA is a frequent type of surgery and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in an outpatient regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safe may have additional impact on decreasing health care cost and may lead to an enhanced recovery and better quality of life.

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

  • Patients undergoing primary or revision Total Knee Arthroplasty in the inpatient setting. Non-pregnant patients older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-IV.

排除标准

  • Patients undergoing outpatient TKA. Chronic opioid use of oral morphine 30mg equivalent per day for last 2 consecutive weeks. Patients with contraindications to the insertion of an adductor canal catheter (severe anatomic abnormalities, local or systemic infection, or a history of previous surgery at the site of catheter placement).

结局指标

主要结局

Catheter dislodgement

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

  • Incidence of catheter insertion related complications(4 hours)
  • Incidence of sensory block(24 hours)
  • Number of attempts for catheter insertion(4 hours)
  • Potential complications related to continuous adductor canal block catheter(24 and 48 hours)
  • Ultrasound assessment of the dislodgement of the catheter(24 hours)
  • Pain intensity(24 and 48 hours)
  • Opioid consumption(24 and 48 hours)

研究者

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

Hermann dos Santos Fernandes

Principal Investigator

University of Toronto

研究点 (2)

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