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临床试验/NCT03862287
NCT03862287Unknown不适用

Is Lidocaine Really Guilty? A Prospective, Randomized, Double Blind Comparison of the Incidence of TNS After Intrathecal Lidocaine Administration vs. Intrathecal Bupivacaine in Patients Undergoing Spinal Anesthesia

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
Transient Neurological Symptoms

研究概览

简要总结

This study will look into the incidence of Transient neurological symptoms (TNS) after the intrathecal use of lidocaine in comparison to intrathecal Bupivacaine.

详细描述

Ever since the introduction of Spinal anesthesia in 1898 by the German surgeon August Bier, the approach gained wide acceptance by the anesthesia community 1. Since that time, the technique has evolved to accommodate a wide variety of surgical procedures, making it one of the most common regional anesthesia modalities used. The advancement of the anesthesia field has led to the advancement of the technique it self, specially the drugs used in it.

A wide range of local anesthetics has been introduced after the initial successful intrathecal use of cocaine. Starting with amylocaine, and later with the introduction of various local anesthetics such as procaine, 2-chloroprocaine, lidocaine, tetracaine, mepivacaine, prilocaine, bupivacaine, with ropivacaine and levobupivacaine being introduced last. Many of these drugs have fallen out of favour due to various reasons, with Lidocaine, procaine, mepivacaine, ropivacaine and bupivacaine still being used in clinical practice 2.

The choice of the local anesthetic used depends on many factors such as the duration of the operation, the type of surgery and the degree of motor blockade desired. With the advancement of surgery and the increase in day surgical cases, a need for a fast acting, short in duration local anesthetic that allows fast recovery and early discharge has emerged. Of all the local anesthetic drugs available, Lidocaine is one of the drugs that fulfills these needs.

Common complications associated with the use of this technique include headache (5%), backache (11%), hypotension, bradycardia, nausea and vomiting (20%), urinary retention, hypothermia and transient neurological syndrome (TNS). More serious complications include total spinal, infection (meningitis/ encephalitis) and epidural hematoma (<1 in 150,000). On the other hand, complications related to receiving General Anesthesia for the same procedure are similar, with higher chances of nausea and vomiting or airway problems.

TNS is defined as back pain and/or dysesthesia radiating bilaterally to the legs or buttocks after total recovery from spinal anesthesia, manifesting within 24 hours after the surgery and typically lasting less than a week. The etiology of TNS is unknown. Possible contributing factors to the development of TNS include sciatic nerve stretching causing neural ischemia, vasoconstriction of spinal cord arteries, patient positioning, direct needle injury and pooling of local anesthetic in the sacral region. The pathophysiology of TNS is unknown, and there is no specific lab test to diagnose this complication. Treatment of TNS, includes bed rest, administration of nonsteroidal anti inflammatory drugs and sometimes the addition of an opioid is needed 3.

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, Outcomes Assessor)

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 male and female patients aged between 18 to 80 years old, who will receive spinal anesthesia for surgeries lasting less than one hour.

排除标准

  • Patients younger than 18 years old.
  • ASA physical status >
  • Immunosuppression or high risk of infection.
  • Contraindications to receiving spinal anesthesia (e.g. coagulation impairment).
  • Patients with psychosis
  • Patients with preexisting back pain.
  • Patients with cognitive impairment
  • Allergies to local anesthetics, analgesics or any medication used in the study.
  • Patients with chronic regular opioid usage
  • Presence of preexisting neurological symptoms.

研究组 & 干预措施

Intrathecal Lidocaine

Active Comparator

Patients will receive spinal anesthesia in the sitting position under strict sterile conditions in the operating room. Using a median or paramedian approach, the spinal needle will be inserted into the L2-3 or L3-4 interspace to reach the subarachnoid space. After confirming the space by free flow of CSF, 60 mg of isobaric preservative-free Lidocaine 2% will be injected. Sedation using propofol infusion (50-100 mcg/kg/min) and fentanyl (0.5-1 mcg/kg) will be given throughout the procedure as required.

干预措施: Lidocaine (Drug)

Intrathecal Bupivacaine

Active Comparator

Patients will receive spinal anesthesia in the sitting position under strict sterile conditions in the operating room. Using a median/paramedian approach, the spinal needle will be inserted into the L2-3 or L3-4 interspace to reach the subarachnoid space. After confirming the space by free flow of CSF, 6 mg of 0.5% isobaric bupivacaine will be injected. Sedation using propofol infusion (50-100 mcg/kg/min) and fentanyl (0.5-1 mcg/kg) will be given throughout the procedure as required.

干预措施: Bupivacaine Hcl 0.5% Inj_#2 (Drug)

结局指标

主要结局

Transient Neurological Symptoms

时间窗: Day 3

To determine the incidence of TNS following the use of intrathecal Lidocaine as compared with Bupivacaine

次要结局

  • Transient Neurological Symptoms(Day 1 and day 3 postoperative)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

JF Asenjo

Professor of Anesthesia

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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