A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Pain Score (Pain Scores on a 0/10 Scale)
研究概览
简要总结
The purpose of this study is to determine whether liposomal bupivacaine (long acting injectable anesthetic) provides greater post operative pain relief compared to the standard post operative pain regiment for tonsillectomy patients.
详细描述
Subjects will be screened in the clinic when being evaluated for indications for tonsillectomy. Once the decision to proceed with tonsillectomy is made, the patient will be given the information on the study, provided time to review the information and interested patients will be consented.
There will be two stages in the study. The first will be the operative stage, which includes the injection during the operation. The second stage is the patient participation stage. During this stage, the patient records the amount of oral pain medication usage, oral intake after their procedure, in addition to their pain scores. These scores are recorded and brought back (or mailed in) to the clinic for collection during the follow up visit, approximately 1 month later (patients will keep records for two weeks). The patients will be freed from participation in the study after the one month visit.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
- •Willing and able to understand and provide written informed consent
排除标准
- •Known pregnancy
- •Women who are currently nursing a child
- •History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder
- •Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation
- •Inability to provide informed consent (patients under guardianship)
- •Known hypersensitivity to local anesthetics
- •History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
- •History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.
- •Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.
- •History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.
研究组 & 干预措施
Liposomal Bupivacaine
Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Pain Score (Pain Scores on a 0/10 Scale)
时间窗: day of surgery, 14 days after surgery
Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated "no pain" and 10 indicated "worst possible pain"
Pain Medication Usage (Milligrams Used)
时间窗: 2 weeks after surgery
Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame
Oral Intake (Patient Recorded Oral Intake)
时间窗: 1 week after surgery
Subjects recorded oral intake over one week after surgery
次要结局
- Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)(4 weeks)
- Number of Subjects With Post-tonsillectomy Bleeding(4 weeks)