Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
Typical postoperative pain control after minimally invasive hysterectomy includes ibuprofen, acetaminophen, and a short course of narcotics. The purpose of this study is to see if adding cyclobenzaprine to this regime improves pain control and lessens narcotic use.
详细描述
The purpose of this study is to gather more information on cyclobenzaprine as part of postoperative pain control. Cyclobenzaprine, aka Flexeril®, is NOT an experimental drug and is already approved by the Food and Drug Administration (FDA) for acute, painful muscle spasms. It is commonly used for muscle-related pain disorders.
This research is being done because prior studies have shown that cyclobenzaprine helps with pain due to muscle spasms. Some studies showed that cyclobenzaprine does help reduce pain scores in patients undergoing abdominal or joint surgery, but the studies are very limited. This study will see if cyclobenzaprine can be used to decrease post-operative pain in patients undergoing minimally invasive hysterectomy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18yo
- •English speaking
- •Undergoing (robotic assisted or classic) total laparoscopic hysterectomy ± unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy
- •If other procedures such as lysis of adhesions, excision of endometriosis, or ureterolysis are indicated based on intraoperative evaluation, those patients may still be included
- •Surgery took place at ChristianaCare Hospitals
- •No allergies or contraindications to standard of care post operative pain medications (acetaminophen, NSAIDs, narcotics) or cyclobenzaprine
排除标准
- •Age <18yo
- •Pregnant, breastfeeding
- •Non-English speaking
- •Primary procedures other than laparoscopic hysterectomy
- •Laparoscopic myomectomy
- •Laparoscopic resection of endometriosis
- •Laparoscopic unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy ± unilateral or bilateral cystectomy without hysterectomy
- •Hysteroscopic procedures
- •Bartholin gland marsupialization
- •Operations that are scheduled as or converted to the open approach
- •Procedures with planned or unplanned bladder or bowel surgery
- •Allergies or contraindications to standard post operative pain control medications (acetaminophen, NSAIDs, narcotics), such as kidney or liver damage/failure, bariatric surgery, history of gastric ulcer, etc.
- •Chronic pain issues, whether self-diagnosed or by a physician, currently undergoing management
- •Currently undergoing medication assisted treatment for opioid use disorder
- •Currently using opioids consistently
- •Allergies or contraindications to cyclobenzaprine:
- •Absolute: use of MAO inhibitors within 14 days, recent heart attack, congestive heart failure, heart block or other conduction abnormalities, cardiac arrhythmias, hyperthyroidism, history of serotonin syndrome
- •Allergies or contraindications to inactive ingredients in Flexeril, such as lactose
- •Patient's receiving gabapentin at baseline or postoperatively, due to potential sedating effects, or other sedating drugs such as scheduled benzodiazepines and barbiturates