Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
研究概览
简要总结
During penile prosthesis surgery, patients are given general anesthesia in combination with other pain drugs. A caudal nerve block (CNB) is a local anesthetic injected near the tailbone, in addition to general anesthesia, which can lower the need for pain drugs.
The goal of this clinical research study is to learn how effective CNBs are in patients who are having penile prosthesis surgery compared to patients who only have general anesthesia by studying how long you stay in the hospital and the level of pain you have after surgery.
This is an investigational study. The general anesthesia and CNB used in this study are FDA approved and commercially available. It is considered investigational to compare the effectiveness of CNBs in penile prosthesis surgery to general anesthesia alone. The study doctor can explain how the study drugs are designed to work.
Up to 104 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
Study Groups and CNB Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.
- If you are assigned to Group 1, you will receive a CNB and general anesthesia during surgery.
- If you are assigned to Group 2, you will only receive general anesthesia during surgery.
You will not know to which group you have been assigned. The CNB will be given to you while you are under general anesthesia. To receive a CNB, a special needle is inserted at the lower part of the back (near the tailbone). A type of local anesthesia is then injected into the sac surrounding the spinal cord that contains the nerves related to the penis.
All participants will also receive general anesthesia as part of their standard care. You will also receive a separate consent form for the surgery that explains the procedure and its risks, including the risks for general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients that consent to participate.
- •Patients undergoing penile prosthesis surgery.
- •Patients that are male.
- •Patients that are 18 years of age or older.
排除标准
- •Patients on chronic pain medications (ie. Chronic = more than once every two days for greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs.
- •Patients with a BMI >
- •Patients with chronic pain syndromes.
- •Patients with hypersensitivity to Ropivacaine/amide-type anesthetics.
- •Prior surgery of the sacrum.
- •Patients taking anti-coagulants or other blood thinning medications prior to surgery during the specified time frames: i) Low molecular weight heparin less than 36 hours prior to surgery. ii) Coumadin less than 5 days prior to surgery. iii) Plavix and NSAIDs less than 7 days prior to surgery.
- •Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically for chronic pain management less than 24 hours prior to surgery
- •Patients on Celebrex less than 24 hours prior to surgery
- •Patients taking more than 81 mg of Aspirin daily
研究组 & 干预措施
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Caudal Nerve Block (CNB) (Procedure)
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Ropivacaine (Drug)
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Epinephrine (Drug)
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Decadron (Drug)
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Clonidine (Drug)
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Propofol (Drug)
Caudal Nerve Block + General Anesthesia Group
Participants receive a caudal nerve block (CNB) prior to surgery and receive general anesthesia during surgery.
Study staff calls participant about 3 days after surgery.
干预措施: Phone Call (Behavioral)
General Anesthesia Alone Group
Participants receive general anesthesia (GA) during surgery without a caudal nerve block.
Study staff calls participant about 3 days after surgery.
干预措施: Propofol (Drug)
General Anesthesia Alone Group
Participants receive general anesthesia (GA) during surgery without a caudal nerve block.
Study staff calls participant about 3 days after surgery.
干预措施: Phone Call (Behavioral)
结局指标
主要结局
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
时间窗: 24 hours
Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain.
次要结局
- Length of Hospital Stay(32 Hours)
- Post-operative Pain the First 24hrs(24 hours)