The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Overall Comfort Level During Injection
研究概览
简要总结
Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will be blind to the solution ratio of each injection, injector will not be blind to solution to ensure safety.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures
- •Any gender, aged 21 - 65
- •In good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus
- •Healthy intact skin on the palmar aspect of both left and right forearms
- •Fluent in English
排除标准
- •Current use of any medication
- •Pregnancy
- •Known allergic reactions to components of the local anesthetic such as sulfites
- •History of vasovagal response to venipuncture or vaccination
- •History of trauma to the forearms i.e., bone breaks, burns, deep lacerations
- •Decreased sensation to the palmar aspect of either forearm
研究组 & 干预措施
Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature
Palmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
干预措施: Cold Compress Pack (Other)
Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature
Palmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
干预措施: Room Temperature Compress Pack (Other)
Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature
Palmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
干预措施: Lidocaine Epinephrine (Drug)
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature
Palmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
干预措施: Cold Compress Pack (Other)
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature
Palmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
干预措施: Room Temperature Compress Pack (Other)
Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature
Palmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order.
干预措施: Lidocaine Epinephrine (Drug)
结局指标
主要结局
Overall Comfort Level During Injection
时间窗: 2 Months
Comfort level during each injection will be scored on a 0 - 10 scale by participants
Pain from Needle Insertion
时间窗: 2 Months
Pain from needle insertion during each injection will be scored on a 0 - 10 scale by participants
Pain from Solution Deposition
时间窗: 2 Months
Pain from solution deposition during each injection will be scored on a 0 - 10 scale by participants
次要结局
- Injection Method Preference(2 Months)
研究者
Nicholas Bastidas
Associate Professor of Plastic Surgery
Northwell Health