Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-Procedural Pain at 4 hours
研究概览
简要总结
Uterine artery embolization (UAE) is a minimally invasive treatment for women with symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. However, the majority of women undergoing UFE experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. Pain is the more common cause of prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce post-procedural pain.
For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention. Hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups.
This is the first Canadian study evaluating lidocaine use for pain control in UFE patients. Results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. It could have a great impact on pain management in women undergoing UFE in all practice settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
- •Indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual bleeding attributed to fibroids, with imaging confirmation;
- •Patient must be able to provide written, informed consent
排除标准
- •Documented of allergy or intolerance to lidocaine or other amide-type anesthetics;
- •Personal or familial history of malignant familial hyperthermia;
- •Documented history of second or third atrio-ventricular heart block
- •Contra-indication to uterine fibroid embolization : active infection, suspected malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid.
- •History of previous uterine fibroid embolization.
研究组 & 干预措施
Lidocaine per-embolization
This group will receive 10mL of 1% lidocaine in both uterine artery during the embolization; the lidocaine will be mixed with the embolization particles.
干预措施: Lidocaine per-embolization (Drug)
Lidocaine post-embolization
10mL of 1% lidocaine will be injected in both uterine arteries after embolization endpoint is achieved.
干预措施: Lidocaine post-embolization (Drug)
结局指标
主要结局
Post-Procedural Pain at 4 hours
时间窗: 4h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS) filled by patients at 4h, 7h and 24h post-procedure. At 4h, patients will report the worst pain they experienced since end of procedure. At 7h and 24h, pain at time of assessment will be recorded.
Post-Procedural Pain at 7 hours
时间窗: 7h post-procedure
Pain will be evaluated using a validated 100mm Visual Analog Scale (VAS)
次要结局
- Narcotic dose(24 hours post-intervention)
- Hospital length-of-stay(24 hours post-intervention)
- Post-Procedural Pain at 24 hours(24 hours post-procedure)
研究者
Dheeraj Rajan
Attending Interventional Radiologist and Associate Professor
University Health Network, Toronto