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临床试验/NCT07050277
NCT07050277招募中3 期

Post-Operative Urinary Retention on Revision Knee Arthroplasty: the Role of Intrathecal Morphine

University of Toronto1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月24日最近更新:
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
50
试验地点
1
主要终点
Postoperative urinary retention

研究概览

简要总结

Revision total knee arthroplasty (rTKA) is a frequently performed procedure. Adequate pain management is an important feature, especially for fast-track and Enhanced Recovery After Surgery (ERAS) programs. The multimodal approach, including single shot or continuous nerve blocks with catheters and spinal or epidural morphine, is a stablished strategy. Although the administration of intrathecal morphine (IM) has been shown to significantly reduce pain scores, it is not free of adverse effects. Postoperative urinary retention (POUR) is possible and might increase the risk of periprosthetic infection. The purpose of this study is to compare patients undergoing rTKAS under spinal anesthesia with IM to patients undergoing the same procedure, under the same anesthetic technique, but with no IM, for POUR and postoperative pain related outcomes. All patients will have single shot and continuous adductor canal block (CACB) and single shot IPACK (interspace between the popliteal artery and the posterior knee capsule) block. The hypothesis is that postoperative pain control is comparable between the groups, with lower incidence of POUR in patients with no IM given.

详细描述

Introduction Total knee arthroplasties (TKA) are among the most performed surgeries worldwide(1). In Canada, between 2020 and 2021, 55,285 TKAs were performed, with 4179 (7.56%) being revision total knee arthroplasties (rTKA). The main reasons for rTKAs are infection (35.6%), aseptic loosening (18.0%) and instability (3.6%)(2). Most TKA are done under a neuraxial anesthetic technique alongside a multimodal approach to postoperative pain management. The approach to postoperative pain management comprises combining intrathecal opioids like morphine, fentanyl; IPACK (interspace between the popliteal artery and the posterior knee capsule) block; adductor canal block (ACB), single shot or continuous with catheters; local infiltration analgesia (LIA) and systemic administration of paracetamol and non-steroid anti-inflammatory drugs (NSAIDs). Oral and intravenous (IV) opioids are usually reserved as rescue medications(3).

In many types of surgeries (lower limbs and abdominal surgeries), intrathecal morphine (IM) administration has been shown to significantly reduce pain scores and postoperative opioid requirements within the first 24 hours. However, its administration has potential side effects, which includes respiratory depression, pruritus, nausea, vomiting and postoperative urinary retention (POUR)(4-7). POUR may require bladder catheterization and can result in delayed hospital discharge and poor patient satisfaction. Ultimately, the need for bladder catheterization increases the risk of periprosthetic infection in hip and knee arthroplasties surgeries(8, 9).

Among primary TKA surgery, there is fair amount of evidence demonstrating equivalence of IM to femoral nerve block or ACB for postoperative analgesia, but at the cost of side effects when IM is used(10, 11). Therefore, for primary TKA surgery, when the proper peripheral nerve blocks are performed, IM is often not used.

A limitation of most of the existing literature focusing on postoperative analgesia in TKA is the exclusion of rTKA surgeries. Consequently, there are very few studies to guide analgesic management specific to rTKA. One study demonstrates that, when a multimodal protocol including continuous ACB (CACB) was performed, patients who underwent rTKA experienced a similar postoperative analgesic course as primary TKA patients(12). Regardless the benefits of peripheral nerve blocks and the potential side effects of IM, the latter is still commonly used for rTKA perioperative management. To the best of our knowledge, there is no prospective study assessing the real analgesic role and potential side effects of IM in addition to peripheral nerve blocks in rTKAs.

Significance Revision TKAs are on a rise following primary TKA. It is a more costly procedure than primary TKA and tends to be more painful. In our institution (Mount Sinai Hospital - Sinai Health System - Toronto, Ontario, Canada), most rTKAs are done under neuraxial anesthesia with IM to achieve optimal pain control. Peripheral nerve blocks (single shot and CACB and IPACK block) are done depending on the presence or absence of contra-indications (anatomy abnormalities, infection on block site). The usage of IM has been shown to be a risk factor for POUR(4, 6), which may require bladder catheterization for its management. This increases the risk for urinary tract infections and subsequently periprosthetic joint infection(8, 9). Despite of the potential side effects, IM is still fairly used for postoperative management in rTKA surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, 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 undergoing unilateral non infected rTKA surgery;
  • Older than 21 years of age, with American Society of Anesthesiologists (ASA) physical status I-III;
  • With no alcohol or drug dependency history;
  • With sufficient understanding and co-operation about the usage of a perineural catheter for pain management; body mass index (BMI) under 45;
  • With no allergy to medications used in the study protocol (bupivacaine, lidocaine, ropivacaine, midazolam, propofol, ketamine, morphine, hydromorphone, fentanyl, acetaminophen, celecoxib, ondansetron, dexamethasone, tranexamic acid);
  • No current or recent use of opioids (within the last 2 weeks) in an average oral morphine equivalent (OME) of 20 mg/day or higher;
  • With no contra-indications for neuraxial anesthesia, IPACK block, ACB and adductor canal catheter insertion;
  • Who speak and understand the English language;
  • Who agrees to participate on this study through the signature of the consent form.

排除标准

  • Patients will be excluded of the study if they have a failed spinal anesthesia and needs for a conversion to general anesthesia;
  • If peripheral nerve blocks are not possible to be performed due to technical difficulties;
  • If during patient's care a deviation of the protocol occurs;
  • If CACB catheter has issues on its function, disconnects or exteriorizes within the first 48 hours of infusion;
  • Or if patient decides to withdraw from the study.

研究组 & 干预措施

Intrathecal Morphine

Active Comparator

Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg + Morphine 100 mcg

干预措施: Intrathecal Morphine (Drug)

No Intrathecal Morphine

Experimental

Adductor canal block; IPACK block; Spinal anesthesia: Isobaric Bupivacaine 0.5% 2.5 mL + Fentanyl 15 mcg

干预措施: No Intrathecal Morphine (Drug)

结局指标

主要结局

Postoperative urinary retention

时间窗: First 48 hours after spinal anesthesia

need of bladder catheterization at any moment

次要结局

  • Quality of Recovery(24 and 48 hours after spinal anesthesia)
  • Pain at rest(24 and 48 hours after spinal anesthesia)
  • Pain at movement(24 and 48 hours after spinal anesthesia)
  • Opioid consumption(24 and 48 hours after spinal anesthesia)

研究者

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

Hermann dos Santos Fernandes

Assistant Professor

University of Toronto

研究点 (1)

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