Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Post Operative Pain Control
研究概览
简要总结
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30
排除标准
- •contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
研究组 & 干预措施
Exparel
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
干预措施: Exparel (Drug)
Bupivacaine HCl with epinephrine
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
干预措施: Bupivacaine HCl with Epinephrine (Drug)
Normal Saline
30mL Normal Saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Post Operative Pain Control
时间窗: up to 4 days
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
次要结局
- Number of Oxycodone Tablets Taken(up to 4 days)
- Postoperative Opioid Consumption - Hydromorphone I.V(1 hour and 2 hours post op)
- Number of Participants With Postoperative Nausea and Vomiting(up to 4 days)
- Number of Participants With Urinary Retention(up to 4 days)
- Number of Participants With Pain During Bowel Movements(Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days)