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临床试验/NCT04916158
NCT04916158Unknown不适用

Evaluation of the Effectiveness of an Accelerated Rehabilitation Protocol Based on Multimodal Analgesia Optimization for Uni-compartmental Knee Prosthesis Surgery: Observational, Prospective, Monocentric "Before-after"

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Test get up and go test measured from day 0 to day 3. The test is successful if the score is >1

研究概览

简要总结

Today, prosthetic replacement for osteoarthritis of the knee is a frequent surgery. In France, nearly 100,000 knee arthroplasties are performed each year . Over the last two decades, there has been growing interest in performing single compartment knee replacement (SKR) surgery in patients with isolated single compartment osteoarthritis. The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) . Pain control is one of the major elements of outpatient management of CKD . Prosthetic knee surgery is very painful, the median pain is rated at 5 out of 10 and on average we use 32 milligrams of morphine . The efficiency of the adductor canal block is effective in this context, it avoids the motor block obtained by the femoral block, therefore interesting for ambulatory management in view of a resumption of the fast walking foreseen for the patient. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that pass through this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia It is therefore often performed with an adductor canal block for multimodal analgesia. This block is performed in several facilities, and data are increasingly emerging on its effectiveness .

Thus, based on the recommendations of the French Society of Anesthesia and Resuscitation, on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 the objective of this study is to evaluate the relevance of a protocol concerning prosthetic knee replacement (PUC) in ambulatory care, based on optimized pain control.

详细描述

In France, nearly 100,000 knee arthroplasties are performed each year . Knee prostheses generate a functional benefit demonstrated in the literature and limited perioperative morbidity and mortality. Over the past two decades, there has been growing interest in the use of single-compartment knee arthroplasty (SKR) in patients with isolated single-compartment osteoarthritis (OA). The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) Improvements in perioperative care with regard to analgesia, anesthesia, but also nursing care and rehabilitation have led to a significant reduction in length of stay. Effective pain management is essential and is a necessary condition for early mobilization and a reduction in length of stay. Cross et al. and Berger et al. have shown that reducing the length of stay of patients hospitalized after knee arthroplasty can be achieved not only without compromising patient safety, but also without compromising patient satisfaction .

Anticipating pain control represents a major asset for ambulatory management. As early as the end of the 1990s, it was demonstrated that pain control is the main parameter in ambulatory surgery .prosthetic knee surgery is a very painful surgery. The efficiency of the adductor canal block is effective in this context. It reduces the motor block obtained at the level of the femoral block, which is particularly interesting for ambulatory management with a view to the patient's planned fast walking. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that travel in this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia,so it is often performed with an adductor canal block in a multimodal analgesic pathway. Although this block is performed in several institutions, data is still emerging on its effectiveness. For example, a randomized trial in a single institution involving 86 patients undergoing GPT revealed that the combination of IPACK, adductor canal block and periarticular infiltration improved postoperative analgesia and reduced opioid consumption compared to periarticular injection alone .

Thus, based on the SFAR recommendations on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 , we set up a protocol for a feasibility study of prosthetic knee replacement (PUC) on an outpatient basis, based on optimized pain control.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with programmed SKR,
  • >18 and < 85 years of age,
  • Score ASA 1-2,
  • No cognitive impairment,
  • No thromboembolic TCDA,
  • Without CI to local anesthetics, analgesics,
  • Accepting outpatient care
  • No opposition formulated

排除标准

  • <18 years and >85 years
  • Patients under legal protection (guardianship, curatorship, ...)
  • Refusal to participate
  • Support for a total knee prosthesis,
  • Emergency surgery or revision surgery,
  • SAOS not fitted,
  • Allergy or hypersensitivity to local anesthetics,
  • Outpatient discharge criteria not met.

结局指标

主要结局

Test get up and go test measured from day 0 to day 3. The test is successful if the score is >1

时间窗: Day 0 to Day 3

次要结局

  • evaluation of visual analogue pain scale up to Day 5 postoperatively(day 5)
  • evaluation of morphine consumption up to Day 5 postoperatively(day 5)
  • evaluation of the patient's recovery by the QOR-15 questionnaire at 24 and 48 hours,(24 and 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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