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临床试验/NCT03597776
NCT03597776已完成4 期

Intravenous Lidocaine in Total Knee Replacement

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
62
试验地点
1
主要终点
Pain assessed by numerical rating scales (NRS) pain scores

研究概览

简要总结

Osteoarthritis of knees and hips is a common medical problem present in elderly, which poses significant impairment to their mobility, independence, and quality of life. Despite the availability of conservative treatment, such as simple analgesics and physiotherapy, total joint replacement is the only curative option for this disease entity.

The latter, however, is not without risk. A study by Poulakka has demonstrated that patients with poor pain control in the postoperative period were three to ten times more likely to develop chronic pain, which may significantly impair the patients' functional status and quality of life.

Optimal pain control is therefore essential in facilitating rehabilitation and in preventing long-term morbidities.

Lidocaine [2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide] is an amide local anaesthetic that is characteristically fast in onset and short in duration of action. As such, it has long been used for providing regional anaesthesia for operation, but with limited role in terms of post operative analgesia.

Recently, intravenous infusion of lidocaine has been shown to be safe and effective in reducing post operative pain (resting and dynamic), opioid consumption, and chronic post-surgical pain. The mechanism of action involves both peripheral and central actions. In addition to blockade of the Voltage-gated Sodium Channel of the peripheral nerves, lidocaine also inhibits priming of the PolyMorphoNuclear granulocyte (PMN) by inducing a time-dependent inhibition of intracellular G-protein signalling molecule (Gq); thus reducing release of cytokines and Reactive Oxygen Species Centrally, lidocaine also causes blockade of NMDA receptors and Neurokinin Receptors of the Wide-Dynamic Range Neurons in the dorsal horn of spinal cord; thus reduces glutamate activity.

We therefore hypothesize that the use of intravenous lidocaine may reduce acute pain and improve the range of knee flexion after total knee replacement. Currently, there is strong evidence supporting its use in laparoscopic and open abdominal surgeries. There is, however, a paucity of studies in orthopedic surgeries. To date, there is no randomized controlled trial that studied its effect in total knee replacement.

详细描述

OBJECTIVE:

The aim of this study is to estimate the effectiveness of a preemptive bolus of intravenous lidocaine on reduction in acute pain, improvement on the range of movement, other rehabilitation parameters and functional scoring in the post-operative period after total knee replacement.

DESIGN:

This is a double-blinded, randomized, placebo-controlled trial.

RECRUITMENT & SAMPLE SIZE:

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • Primary Elective Total Knee Replacement under Spinal Anaesthesia

排除标准

  • Single Stage Bilateral Total Knee Replacement
  • Revision Total Knee Replacement
  • Contraindications to Spinal Anaesthesia or Failed Spinal Anaesthesia
  • Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids
  • Cardiac Disease: Any degree of Heart Block, Heart Failure
  • Neurological: Any Seizure Disorder
  • Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder
  • Alcohol or substance abuse
  • Chronic Pain, other than chronic knee pain
  • Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
  • Impaired Renal Function (defined as preoperative serum creatinine level over 200µmol/L)
  • Impaired Hepatic Function
  • Pregnancy
  • Inability to use PCA
  • Patient Refusal
  • Patients do not understand Cantonese

研究组 & 干预措施

Lidocaine Group

Experimental

Bolus of intravenous lidocaine of 2mg/kg over 5 mins will be given before skin incision.

干预措施: Lidocaine (Drug)

Placebo Group

Placebo Comparator

Normal Saline of 2mg/kg over 5 mins will be given as bolus before skin incision

干预措施: Saline (Drug)

结局指标

主要结局

Pain assessed by numerical rating scales (NRS) pain scores

时间窗: at postoperative day 1

NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded during movement and at rest, by NRS (movement) and NRS (rest) respectively

次要结局

  • Availability of usual activity of knee(until postoperative day 6)
  • Range of motion (ROM) of knee(until postoperative day 6)
  • Side Effects of PCA Morphine(until postoperative day 6)
  • Self Care Assessment(until postoperative day 6)

研究者

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

Dr. Chi-Wai Cheung

Clinical Professor

The University of Hong Kong

研究点 (1)

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