Impact of Liposomal Bupivacaine on Post-operative Pain, Opioid Use, and Swallow Function in Transoral Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Dysphagia with Dysphagia Survey
研究概览
简要总结
This study is for patients with oropharyngeal squamous cell carcinoma. We want to learn more about how we can optimize pain control in patients who undergo transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Our goal is to determine if a local anesthetic called EXPAREL® (Liposomal Bupivacaine) impacts postsurgical pain and swallow function in patients with oropharyngeal squamous cell carcinoma undergoing TORS. EXPAREL® is an FDA-approved anesthetic drug that provides long-lasting and precise pain relief when injected into the surgical wound. Our study team wants to determine if injecting EXPAREL® into the surgical wound will provide better pain relief and swallow function when compared to patients who do not undergo postoperative EXPAREL® injection. Both options for postoperative pain control are considered standard of care for patients undergoing TORS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, greater than or equal to 18 years of age; Patients of all genders; Patients undergoing transoral robotic surgery; Patient who are able and willing to give consent
排除标准
- •Patients with an allergy to Bupivacaine or other amide anesthetics; Patients with a carnitine deficiency
研究组 & 干预措施
TORS + Liposomal Bupivacaine + Postoperative Antipyretics and Opioids Group
Per standard of care, at the conclusion of the TORS procedure, liposomal bupivacaine will be injected into the surgical bed- (bupivacaine liposome suspension 1.3% [13.3 mg/mL], intramuscular) in this group. Possible injection sites include the base of tongue and/or tonsil. Total dose injected will be 3-4 mL. Subjects will also be given a pain regimen including:
- Tylenol 650 mg every 4 hours as needed for mild pain
- Oxycodone 5 mg every 4 hours as needed for moderate pain
- Morphine 2mg every 3 hours as needed for breakthrough pain
The treatment type (TORS +/- Liposomal Bupivacaine + Postoperative Antipyretics and Opioids) is determined by the subject's surgeon based on his standard practice.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Postoperative Dysphagia with Dysphagia Survey
时间窗: 3 months
Patients will undergo an evaluation of their swallow function via the MD Anderson Dysphagia Inventory survey with a speech language pathologist during their first postoperative visit.
Postoperative Dysphagia with Endoscopic Swallow Study
时间窗: 3 months
Patients will undergo a functional endoscopic swallow study with a speech language pathologist during their first postoperative visit.
Postoperative Pain Control
时间窗: 3 months
We will be measuring subjects' postoperative maximum visual analog pain scores on each postoperative day. Scale: 0-10, 0 represents no pain and 10 represents the worst pain
次要结局
- Postoperative Pain Medication Usage(3 months)