Exparel Versus Bupivacaine in Post-operative Pain Control Following Bilateral Third Molar Extractions: A Single-blind Randomized Clinical Trial
概览
- 阶段
- 4 期
- 干预措施
- Bupivacaine liposome injectable suspension
- 疾病 / 适应症
- Liposomal Bupivacaine
- 发起方
- Case Western Reserve University
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- post operative pain
- 状态
- 已完成
- 最后更新
- 19天前
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
研究者
Faisal Quereshy
professor
Case Western Reserve University
入排标准
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 bupivicaine
patient receive mandibular and maxillary infiltrations with 3mL of standard 3mL standard bupivacaine.
干预措施: Bupivacaine liposome injectable suspension
liposomal bupivacaine
patient receive mandibular and maxillary infiltrations with 3mL of 1.3% liposomal bupivacaine (Exparel)
干预措施: Bupivacaine liposome injectable suspension
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