The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.
详细描述
Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy
- •undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
- •Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)
排除标准
- •Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
- •Non-English speaking
- •Allergy to bupivacaine, lidocaine, zinc, silver or menthol
- •Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
- •History of glucose-6-phosphate deficiency
- •Use of anti-arrhythmic drugs such as tocainide or mexiletine
研究组 & 干预措施
Lidoderm patch
Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours.
干预措施: Lidocaine patch (Drug)
Infusion pump
Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively.
干预措施: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr (Device)
结局指标
主要结局
Pain scores
时间窗: post-operative until 60 hours postpartum
Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"
次要结局
- Rescue opioid consumption(post-operative until 60 hours postpartum)
- Survey of nursing staff(between 48-60 hours post-Cesarean delivery)
- Patient survey(between 48-60 hourrs post-Cesarean delivery)