跳至主要内容
临床试验/NCT03004222
NCT03004222
已完成
不适用

A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?

Metro Health, Michigan1 个研究点 分布在 1 个国家目标入组 137 人2015年7月

概览

阶段
不适用
干预措施
Bupivacaine
疾病 / 适应症
Laparoscopic Appendectomy
发起方
Metro Health, Michigan
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.
状态
已完成
最后更新
8年前

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.

注册库
clinicaltrials.gov
开始日期
2015年7月
结束日期
2017年11月
最后更新
8年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Metro Health, Michigan
责任方
Sponsor

入排标准

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

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

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)

研究点 (1)

Loading locations...

相似试验