A Prospective, Randomized, Open-Label Study Comparing Postsurgical Analgesia Using EXPAREL® To Standard Of Care For The Full Arch Surgical Therapy (FAST) Dental Implant Surgery Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 4
- 主要终点
- Postsurgical Pain Severity
研究概览
简要总结
This study is researching managing postsurgical pain by injecting both short-acting local anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or eliminate the need for postsurgical opioids and improve clinical outcomes following the FAST dental implant surgery procedure. This approach is being compared to the current standard of care.
详细描述
Postsurgical pain following the Full Arch Surgical Therapy (FAST) dental implant surgery procedure is commonly managed with a variety of interventions, including local infiltration with short-acting local anesthetics during surgery and the use of postsurgical opioid and non-opioid analgesics. Although this approach to managing postsurgical pain is considered the current standard of care, its reliance on opioid analgesics to provide analgesia beyond the duration of short-acting local anesthetics exposes patients to opioid-related adverse events (ORAEs) that may delay their recovery and have other deleterious clinical consequences. The primary objective of this study is to determine the efficacy and safety of local infiltration of EXPAREL for the FAST dental implant surgery procedure compared to standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older;
- •Ability to speak, read, and write in English;
- •Ability to communicate via telephone;
- •Scheduled to undergo FAST dental implant surgery procedure at a study center within the next 30 days for both maxillary and mandibular repair with at least 4 upper and 4 lower teeth to be extracted;
- •Willing to provide informed consent, participate in study, and comply with study protocol.
排除标准
- •Daily opioid consumption for more than 30 days prior to surgery;
- •Any opioid consumption within 3 days prior to surgery.
- •Prior treatment for alcohol, recreational drug, or opioid abuse.
- •Hypersensitivity or allergy to local anesthetics, non steroidal anti-inflammatory drugs, or opioids;
- •Breastfeeding, pregnant, or contemplating pregnancy prior to surgery.
结局指标
主要结局
Postsurgical Pain Severity
时间窗: 7 days
次要结局
- Analgesic medication use(7 days)
- Incidence of ORAEs and other adverse events (AEs)(7 days)
- Food ingesting tolerance(7 days)
- Patient Satisfaction(7 days)
研究者
Phillip T. Iero
Oral Surgeon
Bellaire Facial Surgery Center