Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators.
研究概览
简要总结
This study is testing a local anesthetic (numbing medicine) to suppress pain. Bupivacaine and lidocaine are FDA approved local anesthetics that may decrease pain following surgery. Patients will receive either 2% lidocaine, 0.5% bupivacaine, or placebo with epinephrine 1:200,000 as a numbing medicine at the end of root canal surgery. Small pieces of gum will be taken before and after surgery and 2 days later to analyze chemicals that may be related to pain sensation.
详细描述
We hypothesize that the use of the LLA bupivacaine will promote local inflammation leading to increased pain and central sensitization as evaluated by increase in pain at later time points. Hence our main hypothesis to be evaluated and statistically tested for our primary endpoint (Aim 1) is:
HO: There is no difference in mean levels of biochemical mediators of inflammation between groups.
HA: The bupivacaine group has higher levels of biochemical mediators following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female volunteers referred for endodontic surgery willing to undergo 2 visits: 1 surgical appointment, and 1 follow-up research-related appointment
- •Ages of 18 and older
- •Willing to undergo observation for 1/2 hour post-operatively
- •Willing to complete a 100 mm visual analog scale and record analgesic intake over 48 hrs period
- •Willing to have a preoperative and postoperative biopsy on the day of surgery
- •Willing to return at 48 hours post-operation to turn in completed pain diaries and for the third biopsy
排除标准
- •Allergy to or other contraindications to use of aspirin, sulfites, amide anesthetics, or acetaminophen
- •Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDS, COX-2 inhibitors, antihistamines, steroids, antidepressants
- •Medications contraindicated with bupivacaine: MAO inhibitors and anti-depressants
- •Diseases such as diabetes mellitus, liver disease, chronic infections, rheumatoid arthritis or any other systemic disease that compromises the immune system
- •Unusual surgical difficulty
研究组 & 干预措施
Lidocaine
2% lidocaine/1:200,000 epinephrine
干预措施: Lidocaine (Drug)
Bupivacaine
0.5% bupivacaine/1:200,000 epinephrine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Assess the local inflammatory response as measured by tissue expression of the prostanoid enzymes cyclooxygenase (COX-2) and other cytokines and inflammatory mediators.
时间窗: 48 hours
The difference in inflammatory gene expression between treatment groups.
次要结局
- Evaluate the clinical outcome of postoperative pain following endodontic surgery, as measured by pain category and visual analog scale (VAS) and postoperative analgesic requirements.(48 hours)
研究者
Sharon Gordon
Associate Professor
University of Maryland