RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect of liposomal bupivacaine on postoperative pain control
研究概览
简要总结
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Data will be encrypted using BRMS
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, greater than 18 years of age
- •ASA Class I or II
- •Ability to take oral medication in order to assess the patient's opioid regimen postoperatively
- •Forefoot surgery, including bunionectomy +/- digital surgery
- •For females of reproductive potential: hCG levels will be determined during the pre-operative period. Females of childbearing age require a hCG level below 5mIU/mL in order to participate in the study. hCG levels above 25 mIU/mL is considered positive for pregnancy and, as a result, the patient will not be considered eligible for inclusion in the study
排除标准
- •Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week
- •Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery
- •Systemic glucocorticoids within 1 month of study enrollment
- •History of hepatitis
- •History of peripheral vascular disease
- •History of diabetes mellitus type 1 or 2
- •Pregnancy or lactation
- •Allergic to opioids
- •Known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to PABA
- •BMI > 40
研究组 & 干预措施
Liposomal Bupivacaine
The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure.
干预措施: Liposomal bupivacaine (Drug)
Bupivacaine HCl
The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure.
干预措施: Bupivacaine HCl (Drug)
结局指标
主要结局
Effect of liposomal bupivacaine on postoperative pain control
时间窗: The study will last 72 hours after the elective procedure.
VAS scores, which measure the intensity of pain on a scale of 1 to 10, will be collected at 2, 24, 48 and 72 hours post-operatively in order to assess therapeutic effect of local anesthetic medication for postoperative pain control.
次要结局
- Effect of liposomal bupivacaine on opioid use(The study will last 72 hours after the elective procedure.)
研究者
Alexandra Black
DPM
Lenox Hill Hospital