Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Post-operative pain
研究概览
简要总结
The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.
详细描述
In this study, we will prospectively collect data from all patients receiving bilateral third molar extractions with Exparel versus 0.5% bupivacaine 1:200,000 epinephrine (standard bupivacaine) injections to determine the efficacy of Exparel in reducing postoperative pain. Outcomes measured will be pain intensity based on a numeric scale, date and time when pain completely subsides for each side, adverse events, use of NSAID or acetaminophen outside of prescribed pain regimen, and use of narcotics. The purpose of this research project is to evaluate the use and efficacy of Exparel in postoperative pain management in third molar extractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
An envelope, which is identified by the patient specific study ID, will contain Exparel and standard bupivacaine syringes. The syringes will be masked and labeled left or right, depending on the randomization results. Designated dental assistants not associated with the study will receive the corresponding envelope to prepare the syringes. Syringes containing the solutions will be masked so that the operator would not be able to detect which solution is being infiltrated.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients receiving bilateral mandibular third molar extractions at the Herman Ostrow School of Dentistry by an oral & maxillofacial surgery resident.
排除标准
- •Patient unable to complete form for four days postoperatively.
- •Patient with severe hepatic disease
- •Patient with a history of allergy or contraindication to amide-type LA or opioids
- •Patient with recent history of antibiotic use within the past thirty days
- •Patients with use of long-acting opioids, NSAIDs, aspirin, acetaminophen within 3 days prior to screening.
- •Patients who are pregnant.
- •Patients receiving additional mandibular teeth extractions.
研究组 & 干预措施
Liposomal bupivacaine
A double-blinded randomization process will be used to preoperatively assign patient's left or right side to receive either Exparel (Liposomal bupivacaine) (39.9 mg/3 mL) or standard bupivacaine (5 mg/mL). At the end of the mandibular third molar extraction surgical procedure and at least twenty minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), all patients will receive one side of their mandibular infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel).
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Post-operative pain
时间窗: 96 hours post-operatively
At home questionnaire with a numerical scale (0 - 10), to be completed each morning and evening for four days post-operative.
次要结局
- Adverse effects(96 hours post-operatively)
- Oxycodone Use(96 hours post-operatively)
- NSAID/Acetaminophen Use(96 hours post-operatively)
研究者
John Costandi
Assistant Professor
University of Southern California