"Comparison of Buffered Versus Non-Buffered Local Anesthetic in Patients With Inflamed Tissues for Pain Perception, Onset, Duration and Adverse Effects"
This study aims to determine whether buffered or non-buffered local anesthetic (LA) is more effective and safer for managing pain in patients with inflamed tissues undergoing surgical procedures. Local anesthetics are widely used to reduce pain, but their effectiveness may vary, particularly in inflamed tissues where achieving adequate anesthesia can be challenging.
In this study, patients will be divided into two groups: one group will receive buffered local anesthetic, and the other will receive non-buffered local anesthetic. The study will compare the level of pain experienced during injection and the procedure, how quickly the anesthetic takes effect, and how long the numbness lasts. In addition, any side effects such as dizziness, nausea, vomiting, allergic reactions, or heart-related complications will be carefully monitored.
The study will also examine whether the presence of co-morbid conditions (such as diabetes, hypertension, or other chronic illnesses) affects the outcomes of both types of anesthetics.
The main question this study seeks to answer is whether buffered local anesthetic provides better pain relief, faster onset, longer duration, and fewer side effects compared to non-buffered local anesthetic, and how these outcomes differ in patients with and without co-morbid conditions. The findings may help improve pain management practices and guide healthcare providers in selecting the most appropriate anesthetic for different patient groups.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Hafiz M Usman
- 电话号码:+923327208618
- 邮箱:usmanyaqoob319@gmail.com
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patient age between 18 and 60 and all gender.
- Patients requiring surgical wound debridement under local anesthesia.
Exclusion Criteria:
- Pregnant women (documented on medical record).
- Patients taking the medications such as narcotics, antidepressants and sedatives from last 3 months that can influence the anesthetic assessment.
- Patients with known allergy to local anesthetics or sulfites documented on previous medical record.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Group A
Group A will get Buffered Local Anesthesia
|
The investigator will add Sodium bicarbonate in lidocaine with adrenaline (1:80,000 ) for Buffered Local anesthesia.
|
|
无干预:Group B
Group B will get Non-Buffered local anesthesia
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain Perception
大体时间:Pain during infiltration will be evaluated at 0 minutes and again at 5 minutes post-infiltration at the onset of surgical procedure and scores will be also taken at 10-minute intervals during the procedure.
|
The level of pain relief achieved by buffered and non-buffered LA will be measured by using Visual Analog Scale from 0 to 10.
The highest score thats is 10 represent the Worst pain, the worst outcome and the minimum score that is 0 represents no pain, desirable outcome.
|
Pain during infiltration will be evaluated at 0 minutes and again at 5 minutes post-infiltration at the onset of surgical procedure and scores will be also taken at 10-minute intervals during the procedure.
|
|
Onset Time
大体时间:Every 30 seconds up to 1/2 hour
|
The duration between the administration of the anesthetic injection and sensation checked by sharp object at the anesthetized site
|
Every 30 seconds up to 1/2 hour
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient satisfaction
大体时间:Up to 24 hours after the procedure
|
Patient satisfaction with pain management post procedure will also be measured on the Scale of 1-5(poor- excellent)
|
Up to 24 hours after the procedure
|
|
Duration of Action
大体时间:Every 30 minutes for up to 4 hours
|
The duration of anesthesia will be measured through sensory testing and patient evaluation after every 30 minutes for up to 4 hours until the sensation returns.
|
Every 30 minutes for up to 4 hours
|
|
Adverse Effects
大体时间:every 30 minutes for up to 2 hours
|
Adverse effects will also be evaluated carefully during the operative procedure and again at 30 minutes, 1 hour, and 2 hours after the operation.
|
every 30 minutes for up to 2 hours
|
|
Co-morbid conditions:
大体时间:Every 30seconds for up to 24 hour
|
The participants in the control group and study group will be stratified based on the predefined co-morbid conditions documented in their medical records such as DM, HTN, IHD, asthma and renal failure.
This stratification will allow the subgroup analyses of the outcome variables of the buffered and non buffered local anesthetic across different clinical profile.
|
Every 30seconds for up to 24 hour
|
合作者和调查者
调查人员
- 首席研究员:Hafiz M Usman、King Edward Medical University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 631/RC/KEMU
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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