跳至主要内容
临床试验/NCT03021772
NCT03021772已完成2 期

Efficacy of Neostigmine Versus Dexamethasone as Adjuvants to Lidocaine During Intravenous Local Anesthesia for Forearm Orthopedic Surgeries

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Pain assessed on VAS

研究概览

简要总结

Intravenous regional anesthesia (IVRA) is described firstly in 1908 by August Bier. It is simple, safe, reliable, less cost, efficient method in forearm surgery. The advantage of this method has fast return of motor and sensory function which enables patients for earlier discharge. However, this method has disadvantages such as tourniquet pain, insufficient muscle relaxation and postoperative analgesia.

Lidocaine inhibits action potential propagation within neuronal tissue by binding to receptors in Na+ channels located on the nerve cell membrane. Lidocaine IVRA is safe and effective and is associated with a rapid onset (4.5 minutes) of anesthesia after injection and termination of analgesia (5.8 ± 0.5 minutes) once the tourniquet is deflated.

Neostigmine is a typical cholinesterase inhibitor. It increases the level of acetylcholine (Ach) and indirectly stimulates both nicotinic and muscarinic receptors. In anesthesia, neostigmine is a drug that has been used for reversal of residual neuromuscular block. Administration of neostigmine by intrathecal and epidural routes has been found to cause analgesia by inhibition of the breakdown of Ach in the spinal cord.

Dexamethasone is commonly used in anesthesia to prevent postoperative nausea and vomiting (PONV). Two recent meta-analyses have documented that dexamethasone also reduced postoperative pain and opioid requirement. Intravenous dexamethasone has also been shown to improve postoperative pain control in patients receiving spinal or epidural morphine.

Hong et al reported that intravenous dexamethasone in combination with a caudal block with ropivacaine prolonged the duration of postoperative analgesia without adverse effects in children undergoing orchidopexy. So the investigators expect that addition of dexamethasone or neostigmine will affect duration and postoperative analgesia in bier block.

详细描述

This study will be a prospective clinical randomized controlled double-blind study using a computer-generated randomization. Neither the doctor "investigator" nor the participant "patient" will be aware of the group allocation or the drug used. The study drugs will be prepared by one of the supervisor anesthesiologists (not included in the procedure, observation or data collection).

The study will be carried out in Assiut University Hospital after approval from our local ethical committee.

Patients

The patients will be classified in two groups:

According to sample size calculator. Group D: will include 30 patients and will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 8 mg dexamethasone for bier block.

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 - 60 years.
  • ASA grade I - II.
  • Surgical time does not exceed 90 minutes.

排除标准

  • Patient refusal.
  • Any contraindication of regional anesthesia block (e.g. Coagulopathy, infection at the needle insertion site or vascular insufficiency).
  • A personal history of seizures, peripheral neurologic diseases, cardiac arrhythmias, sickle cell anemia, liver dis¬ease, renal dysfunction and cardiac conduction abnormalities.
  • Patients with allergy to amide local anesthetics or medication included in the study.

研究组 & 干预措施

Group N

Active Comparator

30 patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 0.5 mg neostigmine for Bier block.

干预措施: Neostigmine (Drug)

Group D

Active Comparator

30 patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 8 mg dexamethasone for Bier block.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Pain assessed on VAS

时间窗: 24 hours

perfalgan will be given when visual analogue score ≥ 4

次要结局

  • Motor level(2 hours)
  • Sensory level(2 hours)
  • Number of patients with any complications(24 hours)

研究者

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

MOHAMED F. MOSTAFA

Lecturer of Anesthesia and Intensive Care

Assiut University

研究点 (1)

Loading locations...

相似试验