A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Total narcotic use following surgery until the time of discharge from the hospital.
研究概览
简要总结
The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.
详细描述
The purpose of this study is to determine the effectiveness of using intraperitoneal anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5% bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively. Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic appendectomy will decrease the amount of narcotic a patient uses postoperatively. Secondarily, this study will attempt to determine if there is a decrease in length of stay for the subjects randomized to the anesthetic infiltration.
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 (Investigator)
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
- •Patients 18 years of age and older
- •Laparoscopic appendectomy at Metro Health Hospital
排除标准
- •Adults unable to consent Non-English speaking patients
- •Suspected or known malignant disease
- •Patients with known allergies to the local anesthetic
- •Utilizes opioid pain medicine for a chronic condition
- •Elective laparoscopic appendectomy
- •Known allergy or contraindication to ketorolac
研究组 & 干预措施
Local anesthetic (Bupivicaine)
The experimental arm intervention is 75 subjects will receive the study agent (20 mL of 0.5% bupivacaine) to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred
干预措施: Bupivacaine (Drug)
Placebo 20 ml
75 subjects will be treated with normal saline/placebo to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred
干预措施: Placebos (Drug)
结局指标
主要结局
Total narcotic use following surgery until the time of discharge from the hospital.
时间窗: 1, 2, 4 hours
次要结局
- Time to Discharge(12 hours)
- Pain Level Scores at 1, 2, 4, and 12 hours postoperatively(12 hours)