At a glance
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Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery
In Brief
A Phase 3 clinical trial evaluating Caudal Nerve Block (CNB), Ropivacaine, and 5 other interventions for Malignant Neoplasms of Male Genital Organs. Completed, enrolled 52 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg.
Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.
Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.
Decadron 10 mg by bolus injection given by anesthesiologist in OR.
Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.
General anesthesia given in the OR using Propofol titrated for induction.
Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.