Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- post operative pain
研究概览
简要总结
This is a prospective, randomized study to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine
详细描述
The main purpose of this prospective, randomized study was to evaluate anaesthetic parameters, postoperative analgesia and oral analgesic consumption comparing exparel (liposomal bupivacaine) vs. standard bupivacaine. At the end of the third molar extraction surgical procedure and at least fifteen minutes following the most recent administration of 2% lidocaine with 1:100,000 epinephrine (routine for this procedure), patients will, at random, receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel) or with standard 3mL standard bupivacaine. Electronic home questionnaires will be completed by the patient following the procedure for 96 hours to evaluate these clinical parameters
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and nonpregnant female adults (≥18 years of age) with American Society of Anesthesiologists physical status classification 1, 2, or 3 who were scheduled to undergo bilateral third molar extraction (extraction of all 4 third molars) under local anesthesia and general anesthesia Study participants were required to have full or partial bony impaction of both mandibular third molars.
排除标准
- •history of allergy or contraindication to amide-type local anesthetics, epinephrine, or opioids a history of any disease or condition or recent use of any drug that, in the opinion of the investigator, might increase the risk of surgery or interfere with study evaluations any use of long-acting opioids, nonsteroidal anti-inflammatory drugs, aspirin, or acetaminophen within 3 days before screening or use of opioids within 24 hours of screening Patient that is pregnant or suspected to be pregnant Adults that cannot speak English, adults that are unable to consent on their own, or persons that are listed as vulnerable individuals will not be part of the study
研究组 & 干预措施
standard bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 0.5% standard bupivacaine.
干预措施: Bupivacaine liposome injectable suspension (Drug)
liposomal bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
干预措施: Bupivacaine liposome injectable suspension (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
NSAID/Acetaminophen use
时间窗: 96 hours post-operatively
Ibuprofen 600mg \[Advil\], Tylenol) Use
Adverse effects
时间窗: 96 hours post-operatively
At home questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache.
Norco 5/325 (Hydrocone-Acetaminophen) Use
时间窗: 96 hours post-operatively
At home questionnaire including the dosage, time, quantity and reason for use
Post Operative Pain Intensity (Visual Analog Scale VAS)
时间窗: Twice daily (morning and evening) from 0-96 hours post-operatively
Post operative pain was assessed using 0-10 Visual Analog Scale (VAS) where 0 indicates no pain and 10 indicates worse imaginable pain. Patients recorded pain score twice daily (morning and evening) for four consecutive post operative days using a standardized at home questionnaire
次要结局
- Post Operative NSAID/Acetaminophen Consumption(Daily from 0 to 96 hours post-operatively)
- Post Operative Opioid Consumption (Hydrocodone-Acetaminophen 5/325) Use(daily from 0 to 96 hours post-operatively)