跳至主要内容
临床试验/NCT05280704
NCT05280704终止不适用

Traditional Dorsal Digital Block Vs Volar Subcutaneous Digital Block

University of Arkansas2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Injection Pain

研究概览

简要总结

This is a prospective, randomized, double-blinded controlled trial comparing two different techniques for digital blocks. Participants will be physicians who perform digital blocks as part of their everyday duty. Each participant will undergo two digital blocks and will have the opportunity to perform a digital block on another participant.

This study follows a two-period cross-over design with four groups that are defined by the sequence of treatments within each group. Participants will receive two digital blocks, one using the traditional dorsal technique and one using the volar technique. Of the two injections, one of the syringes will contain 1% lidocaine without epinephrine and the other will contain sterile normal saline. The injections will be to the index finger on each hand. The hand injected first will be up to the participant. The order in which the dorsal technique versus the volar technique is performed will be randomized. Participants will not be told one of the syringes contains normal saline. Injection pain will be measured by visual analog score and recorded after each injection. Sensation in each of the 12 zones of the finger will be recorded at each minute mark until loss of sensation in all 12 zones is achieved or 15 minutes has passed, whichever comes first.

详细描述

This is a prospective, randomized, double-blinded controlled trial comparing two different techniques for digital blocks. Participants will be physicians who perform digital blocks as part of their everyday duty. Each participant will undergo two digital blocks and will have the opportunity to perform a digital block on another participant.

This study follows a two-period cross-over design with four groups that are defined by the sequence of treatments within each group. Participants will receive two digital blocks, one using the traditional dorsal technique and one using the volar technique. Of the two injections, one of the syringes will contain 1% lidocaine without epinephrine and the other will contain sterile normal saline. The injections will be to the index finger on each hand. The hand injected first will be up to the participant. The order in which the dorsal technique versus the volar technique is performed will be randomized. Participants will not be told one of the syringes contains normal saline. Injection pain will be measured by visual analog score and recorded after each injection. Sensation in each of the 12 zones of the finger described by Cummings et al will be recorded at each minute mark until loss of sensation in all 12 zones is achieved or 15 minutes has passed, whichever comes first.

Set Up Prior to Study Performance Four-digit codes will be created for all participants. The 4-digit codes will be randomly assigned to a treatment group, A, B, C and D. Group A will undergo the volar technique first with lidocaine (V1) and then the dorsal technique second with sterile saline (D2). Group B will undergo the volar technique first with sterile saline and then undergo the second injection with the dorsal technique with lidocaine. Group C will undergo the dorsal technique first with lidocaine (D1) and then the volar technique second with sterile saline (V2). Group D will undergo the dorsal technique first with sterile saline followed by the volar technique second with lidocaine. Two syringes will be prepared for each 4-digit code, one with 4 mL of 1% lidocaine and 4 mL of sterile normal saline. They will be labelled with the four-digit code and a separate letter-digit code. The letter-digit code will contain one letter, either V or D, and one number, 1 or 2. The letter corresponds to the technique used to perform the injection (V for volar technique, D for traditional dorsal technique). The number corresponds to the order to which the syringe is to be used, first or second. Figure 1 shows a typical example of how a syringe will be labelled. In this example, participant 4883 in Group A would receive a syringe of lidocaine labelled 4883 V1 and a syringe of saline labelled 4883 D2. Each syringe will also be marked with an * indicating lidocaine and a # indicating sterile saline. This is added to the syringes to immediately determine the syringe contents in case of adverse reaction. The meaning of the * and # will not be shared with participants but will be known to all members of the study team.

Date of Study

An anonymous survey will be given to all participants with three questions:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Each participant will collect two syringes with a code indicting the order and technique of injection. The contents of the syringe (lidocaine vs normal saline) will not be known by the care provider, outcomes assessor or participant.

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

  • Physicians over the age of 18 who regularly perform digital blocks as part of their duty, including those who specialize in Orthopaedic Surgery, Pediatrics, Family Medicine and Emergency Medicine.

排除标准

  • Participants with absence of an index finger on either side
  • Pregnancy
  • Neuropathy
  • Hematologic disease
  • Peripheral vascular disease
  • Participants with a history of adverse reactions to lidocaine

结局指标

主要结局

Injection Pain

时间窗: Immediately upon injection

The primary outcome is injection pain as measured by the visual analog score (VAS). The VAS for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient indicates a point on the line that matches the amount of pain he or she feels. Data for this outcome will be analyzed using mixed-models ANOVA with Subject as the random effect. The fixed effects in the ANOVA model will be the Technique main effect, the Agent main effect, the Technique-x-Agent interaction, and the Order main effect. Because each subject's two treatments will be administered to opposite hands, there should be no carryover effects, and the ANOVA model accordingly will not include Order interactions with Technique or Agent.

次要结局

  • Efficacy of Desensitization(Pinprick sensation will be tested in all 12 zones of the finger and recorded by the recorder at each minute mark up to 15 minutes or loss of sensation in all 12 zones, whichever comes first.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验