A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual-analogue Pain Scale
研究概览
简要总结
The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Patient is blind to local anesthetic being administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
- •≥ 18 years old.
排除标准
- •History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review)
- •Current or prior history of alcohol or drug abuse (illicit or prescription)
- •History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.)
- •History of cardiac arrhythmia or untreated severe cardiovascular disease
- •Uncontrolled hypertension
- •Hepatic insufficiency
- •Renal insufficiency (CKD stage IIIa or greater)
- •Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement
- •Poorly controlled diabetes mellitus (defined as HgbA1c > 8.5 within 30 days of surgery)
- •Concurrent adjunctive operative procedures planned at the time of penile prosthesis placement (examples: male urethral sling, Peyronie's disease straightening with penile plication or incision/grafting)
- •Concurrent non-prosthetic surgery planned at the time of penile prosthesis placement (examples: circumcision, hernia repair, hydrocelectomy, etc.)
- •Planned infrapubic or subcoronal incision at the time of penile prosthesis placement
- •Patients who will be undergoing prosthesis placement using local, monitored, or spinal anesthesia (i.e. non-general anesthesia)
- •Allergy or history of intolerance to any local anesthetic agents included in the protocol
- •History of prior penile prosthesis or artificial urinary sphincter surgery
- •Revision penile prosthesis surgery
研究组 & 干预措施
Receiving Ropivacaine
Patients receiving Ropivacaine.
干预措施: Randomization of two local anesthetics. (Drug)
Receiving Liposomal Bupivacaine
Patients receiving Liposomal Bupivacaine.
干预措施: Randomization of two local anesthetics. (Drug)
结局指标
主要结局
Visual-analogue Pain Scale
时间窗: post-operative day 14
Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain). Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Visual-analogue Anxiety Scale
时间窗: post-operative day 14
Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10. Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety). Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
次要结局
未报告次要终点
研究者
Matthew (Matt) J. Ziegelmann
Principal Investigator
Mayo Clinic