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临床试验/NCT03145584
NCT03145584已完成不适用

A Comparison of the Effects of Continuous and Single-Shot Adductor Canal Blocks on Analgesia and Knee Flexion Following Total Knee Arthroplasty

University College Cork1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Degree of active knee flexion

研究概览

简要总结

Pain following total knee arthroplasty (TKA) is associated with delayed recovery, impaired mobility, increased morbidity, longer hospital stay and greater cost. Adductor canal block has recently been shown to improve the pain control of patients following TKA. It is not known whether a single shot technique or a continuous catheter-based infusion technique provides optimal analgesia. The investigators hypothesize that a continuous technique would provide better analgesia and permit patients to achieve objective measures of recovery following TKA than a single shot technique.

详细描述

Introduction

Total knee Arthroplasty (TKA) is the standard treatment for knee osteoarthritis, which affects millions of people world wide. In 2008, more than 600,000 TKAs were performed in the United States. This number represents more than double the number performed in 1999 and is estimated to increase by more than 500 % (from the 1999 value) by 2020.

Severe postoperative pain occurs in 60% and moderate pain in 30% of patients undergoing TKA. In addition, the intensity of acute postoperative pain correlates with the risk of developing a persistent post surgical pain which can be chronic and debilitating. Thus, the management of pain following TKA is an important determinant of a patient's long term functional outcome. In addition, recovery from TKA requires extensive and effective postoperative physiotherapy (PT), itself a painful event following TKA. Physiotherapy ensures good range of motion and prevents complications such as tissue retraction, adhesion formation and muscle atrophy, all of which may compromise achievement of long term recovery milestones. Thus, the anesthesiologist caring for patients undergoing TKA attempts to provide a postoperative analgesic regimen which ensures that the patient is as pain free as possible while ensuring that the patient has sufficient motor strength to participate actively in PT.

The need to find non-narcotic alternatives for post surgical pain management has become even more urgent recently due to the recent epidemic of narcotic-related deaths. In the United States the number of opioid related deaths since 1999 has reached almost half a million which represents a four fold increase in incidence, and at least half of opioid related deaths involve prescription drugs. Hence effective non-narcotic approaches to pain management hold great importance not only for clinical care but also for public health on a larger scale.

Previously, intravenous, intrathecal or oral opioids were the mainstay of postoperative analgesia following TKA. Although variably effective, the resulting analgesia is associated with well recognized adverse effects including nausea, vomiting, pruritus and sedation. Each adverse effect is unpleasant and likely to impede recovery and participation in PT. Epidural catheters and femoral nerve blocks have both been used for postoperative analgesia in this setting, but each is associated with lower limb motor weakness which hinders early implementation of PT and may increase the risk of falls.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Scheduled unilateral total knee arthroplasty,
  • ASA physical status I to III,
  • age > 18 years.

排除标准

  • Body Mass Index >35,
  • pre-existing lower extremity neurologic abnormalities,
  • infection, history of chronic opioid use,
  • pregnancy, contraindications to peripheral nerve block or central neuraxial blockade,
  • allergy or contraindications to local anesthetics or drugs that would be used for multimodal analgesia,
  • inadequate command of English
  • refusal of spinal anaesthetic

研究组 & 干预措施

Continuous Adductor Canal Saphenous Catheter

Active Comparator

Participants in this group were randomly allocated to receive a perineural catheter placed at the time of adductor canal block (ACB). The ACB was performed under ultrasound guidance and a 10ml injection of 0.5% bupivacaine was administered adjacent to the saphenous nerve. A PERINEURAL CATHETER WAS INSERTED IMMEDIATELY AFTER INJECTION OF THE INITIAL BOLUS OF LOCAL ANAESTHETIC. THE CATHETER WAS CONNECTED TO A PAJUNK FUSERPUMP CONTAINING 350 ML OF 0.15625% BUPIVACAINE AND INFUSED AT 8ML/HR.

干预措施: Continuous Bupivacaine via Adductor Canal Saphenous Catheter (Drug)

Single Shot Adductor Canal Saphenous Block

Sham Comparator

Participants in this group were randomly allocated NOT to receive a perineural catheter placed at the time of adductor canal block (ACB). The ACB was performed under ultrasound guidance and a 10ml injection of 0.5% bupivacaine was administered adjacent to the saphenous nerve. A SHAM CATHETER WAS PLACED ON THE SURFACE OF THE LEG AND COVERED BY AN OPAQUE DRESSING TO CONCEAL THE INSERTION SITE. ALL PATIENTS HAD THE PROXIMAL END OF THEIR CATHETER ATTACHED TO PORTABLE ELASTOMERIC PUMPS (PAJUNK FUSERPUMP 350 ML) CONCEALED IN OPAQUE BAGS TO PREVENT PATIENTS AND ASSESSORS FROM DETERMINING WHICH PUMPS WERE ACTUALLY FUNCTIONING. THESE PUMPS FUNCTION WITHOUT A MOTOR AND SO MAKE NO SOUND.

干预措施: Single Shot Adductor Canal Saphenous Block with Bupivacaine (Other)

结局指标

主要结局

Degree of active knee flexion

时间窗: During the post operative physiotherapy session on Post-operative Day (POD) 2

The degree of active knee flexion was measured during physiotherapy using callipers

次要结局

  • Numerical rating pain score (NRS)(After physiotherapy POD 2)
  • TUG Test(POD 2)
  • Degree of active Knee Flexion(POD 1)
  • Cumulative Oxycodone Consumption(48 hours)

研究者

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

Brian Declan O'Donnell

Consultant Anaesthetist and Clinical Senior Lecturer

University College Cork

研究点 (1)

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