Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Scores 48 Hours After Surgery
研究概览
简要总结
The study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men scheduled for surgical sperm retrieval for infertility
- •Men 18 years and older who can provide informed consent
- •No documented allergy to bupivacaine or celecoxib
排除标准
- •Prior history of substance abuse
- •Any narcotic use within the last 3 months
- •Concomitant use of aspirin
- •Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
- •Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
研究组 & 干预措施
Liposomal Bupivacaine
Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
干预措施: Liposomal Bupivacaine (Drug)
Standard Bupivacaine
Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
干预措施: Standard Bupivacaine (Drug)
结局指标
主要结局
Pain Scores 48 Hours After Surgery
时间窗: First 48 hours after surgery
Every 8 hours in the first 48 hours post-surgery, subjects were prompted to report their pain score on the 11-point numerical pain rating scale, NRS-11 (Numerical Rating Scale, 11 points). 0 indicates no pain and 10 indicates worst possible pain. Each subject's pain scores were then plotted against time, and the area under the curve was then computed. The minimum composite score would be 0 (no pain ever reported), and the maximum composite score would be 480 (maximum pain (score of 10) reported each time across 48 hours).
次要结局
- Pain Scores 7 Days After Surgery(First 7 days after surgery)
- Pain Scores 60 Hours After Surgery(First 60 hours after surgery)
- Narcotic Requirement(First 7 days after surgery)
- Time to Narcotic Rescue(First 7 days after surgery)
- Percentage of Patients Not Requiring Any Narcotics(7th day after surgery)
- Pain Control Satisfaction(7th day after surgery)