drugset / Trial / NCT02740127

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

NCT02740127

RandomizedParallel-groupSingle-blindSupportive care

Summary

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.

Timeline

Start
2016-06
Primary completion
2020-05-10
Completion
2020-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonidine Other / unclassified 100 ug Other
Subject Dexamethasone Small molecule 10 mg Other
Subject Epinephrine Other / unclassified Other
Subject Ropivacaine Other / unclassified 1 % Other
Subject Ropivacaine Other / unclassified 5 mg/kg Other
Background Propofol Small molecule