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"Comparison of Buffered Versus Non-Buffered Local Anesthetic in Patients With Inflamed Tissues for Pain Perception, Onset, Duration and Adverse Effects"

2026年5月13日 更新者:King Edward Medical University

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

研究类型

介入性

注册 (估计的)

68

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hafiz M Usman、King Edward Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年4月1日

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)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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