This randomized phase III trial studies caudal nerve block to see how well it works compared with general anesthesia in reducing post-operative pain in adult patients undergoing penile prosthesis surgery. A caudal nerve block is a local anesthetic injected near the tailbone which may help reduce the level of pain and length of hospital stay after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02740127.
PRIMARY OBJECTIVES:
I. To determine whether the use of a caudal nerve block (CNB) in combination with general anesthesia (GA) in patients undergoing penile prosthesis surgery results in decreased post-operative pain medication usage compared with patients having GA-only.
SECONDARY OBJECTIVES:
I. To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score.
II. To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in a decreased length of hospital stay compared with patients having only general anesthesia.
OUTLINE: Patients are randomized to 1 of 2 groups.
Group I: Patients undergo CNB via injection to the caudal canal comprising ropivacaine hydrochloride, epinephrine, dexamethasone, and clonidine hydrochloride prior to surgery and receive propofol during surgery.
Group II: Patients receive propofol during surgery.
After completion of study, patients are followed up within 10 minutes, every 15 minutes until hospital discharge, and at 3 days.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBobby Bellard
