Comparison of Two Techniques of Administering IV Lidocaine in Reducing Propofol Injection Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient Expression of Pain
研究概览
简要总结
Intravenous lidocaine is commonly given through an intravenous (IV) line prior to injection of propofol to reduce the amount of pain during propofol injection. The investigators want to study if giving the lidocaine through the IV while the forearm on the same limb has a tourniquet applied to it to prevent "washing out" of the lidocaine prior to propofol injection helps reduce propofol injection pain.
详细描述
The investigators expect that tourniquet lidocaine is superior to straight non-tourniquet lidocaine in reducing propofol injection pain. The investigators also wanted to determine the association of tourniquet duration on reduction of pain with propofol administration. Small studies indicate that 60 seconds of tourniquet lidocaine is superior to 30 seconds or less of tourniquet duration or mixed lidocaine/propofol for injection. The investigators suspect many clinicians do not use the 60-second tourniquet technique due to the extra time involved but hypothesize that a more practical application by applying the tourniquet as soon as the patient is positioned on the operating table will not only be more widely adopted by clinicians as it does not cause delay but also provide the necessary amount of time for benefit from the tourniquet. The investigators also wanted to record the time from tourniquet application to start of propofol administration, which the investigators predict would be at least 60 seconds to see if there is a correlation between duration of venous stasis of IV lidocaine and pain benefit.
Methods and Measures
Design This was conducted as a randomized controlled trial of two methods of administering lidocaine prior to propofol injection.
Setting The study setting was located within North Carolina Baptist Health, an academic medical center, in the Endoscopy Suite or Outpatient Surgery Center where subjects were scheduled to receive propofol as part of their sedation or anesthetic.
Sample Size The investigators estimated that 25 subjects in each of the two groups was required to test the hypothesis based on prior studies.
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
- Single (Participant)
盲法说明
The participant is not told which group they are randomized to. However, a tourniquet is applied in the experimental group, thus some subjects may reason that they are in the experimental group. The study coordinator is aware which group the subject is in.
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
- 否
入选标准
- •Any subject at North Carolina Baptist Hospital scheduled for a procedure in which they will receive propofol for sedation or anesthesia and will not be receiving any other medications prior to the propofol injection.
- •Cases must be schedule to have a duration less than 60 minutes.
排除标准
- •Subjects are excluded if they cannot verbalize a rating of pain
- •Subjects are excluded if they require intravenous medications prior to the study period
研究组 & 干预措施
Intravenous lidocaine: tourniquet
Lidocaine injection tourniquet
干预措施: Lidocaine injection tourniquet (Drug)
Intravenous lidocaine: flushed
Lidocaine injection flushed
干预措施: Lidocaine injection flushed (Drug)
结局指标
主要结局
Patient Expression of Pain
时间窗: During injection at beginning of study; lasts 10 seconds one time only
Patient's verbal rating of pain during injection (see link to study protocol) We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question: How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale: * None (0) * Mild (1) * Moderate (2) * Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome).
次要结局
- Subject's Recall of Injection Discomfort(This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only)
- Investigators Rating of Patient Discomfort(During injection at beginning of study period; lasts 10 seconds one time only)