Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Needle Placement Pain Score
研究概览
简要总结
The purpose of this study is to determine if creation of a skin wheel with bacteriostatic normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar level of anesthesia compared to 1% lidocaine. Participants will receive both types of anesthesia, in random order.
详细描述
Most chronic pain procedures or injections utilize medications (e.g. local anesthetics) to numb the skin in an effort to reduce procedure-related pain; however, they can also be a significant cause of pain leading the patient to abort the procedure. Studies have looked at alternative medications and techniques that lessen the pain but still provide similar levels of anesthesia ("numbing"). One such alternative medication is normal saline that includes benzyl alcohol. Studies researching this specific medication have usually examined procedural pain related to drawing blood or placing an intravenous (IV) catheter but not for chronic pain related procedures.
This is a single site randomized double-blinded clinical trial that will compare the standard of care (1% lidocaine) with bacteriostatic normal saline (saline with benzyl alcohol) administered as a skin wheal during a diagnostic procedure in patients with chronic low back pain. The order of administration of the medication will be randomized and the medication will be blinded to both the subject and the investigator performing the procedure. Skin wheals will be created with each medication, and the subject's level of pain will be assessed after each one to measure how painful the creation of the skin wheal was. Then, a spinal needle for the diagnostic procedure will be placed through the skin wheal and the subject's level of pain will be assessed after each one to measure the level of anesthesia (or numbing) that each one provides. The objectives of this study are to determine if administration of bacteriostatic normal saline causes less discomfort than 1% lidocaine and provides a similar level of anesthesia/numbing for the procedure.
The study will take place at the Grady Pain clinic and participants will be identified from patients that are scheduled to undergo a specific low back procedure - diagnostic lumbar medial branch block. This research study will help identify potential alternatives to the standard of care for numbing of skin during chronic pain procedures that may reduce procedure-related pain and discomfort thus making the procedure more tolerable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for an initial lumbar medial branch block
排除标准
- •Allergy to local anesthetics
- •Fibromyalgia
- •Inability to provide informed consent in English
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Bacteriostatic Normal Saline then 1% Lidocaine
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
干预措施: Bacteriostatic Normal Saline (Drug)
Bacteriostatic Normal Saline then 1% Lidocaine
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
干预措施: 1% Lidocaine (Drug)
1% Lidocaine then Bacteriostatic Normal Saline
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.
干预措施: Bacteriostatic Normal Saline (Drug)
1% Lidocaine then Bacteriostatic Normal Saline
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.
干预措施: 1% Lidocaine (Drug)
结局指标
主要结局
Needle Placement Pain Score
时间窗: Day 1
Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.
次要结局
- Skin Wheal Pain Score(Day 1)
研究者
Brian Bobzien
Assistant Professor
Emory University
