Clinical trial NCT02740127
Conditions: Malignant Neoplasms of Male Genital Organs
Keywords: Malignant neoplasms of male genital organs Adult Penile Prosthesis Surgery Caudal nerve block CNB General anesthesia GA Ropivacaine Naropin Epinephrine Decadron Dexamethasone Clonidine Propofol Diprivan
Sponsor: M.D. Anderson Cancer Center
Start date: 2016-06-01; Completion date: 2020-05-10
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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.

After Surgery Data Collection:

During the 24 hours after surgery, the study staff will ask you to rate your pain on a scale of 0-10. You will be asked to rate your pain about every 30 minutes while you are in the hospital, but you may be asked to rate your pain more often if needed. It should take less than 5 minutes each time to rate your pain. Depending on how you rate your pain, additional pain drugs may be given to you as part of your standard care.

If you are discharged from the hospital on the same day as your surgery or if you are discharged before a member of the staff can ask you to rate your pain, the study staff will call you within 24 hours after you have been discharged from the hospital. This call should last about 5-10 minutes.

The amount of pain drugs given to you before, during, and after surgery will also be recorded.

About 3 days after your surgery, the study staff will call you to ask about your pain, the amount of pain drugs you have taken, and how satisfied you are with the type of anesthesia and pain control you have received. This call should last about 5-10 minutes.

Length of Study:

Your participation in this study will be over after the phone call about 3 days after your surgery has been completed.

Arms: arm 1: 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. arm 2: Participants receive general anesthesia (GA) during surgery without a caudal nerve block.

Study staff calls participant about 3 days after surgery.
Interventions: intervention 1: Caudal Nerve Block (CNB) intervention 2: Ropivacaine intervention 3: Epinephrine intervention 4: Decadron intervention 5: Clonidine intervention 6: Propofol intervention 7: Phone Call
Intervention descriptions: intervention 1: 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. intervention 2: Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR. intervention 3: Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR. intervention 4: Decadron 10 mg by bolus injection given by anesthesiologist in OR. intervention 5: Clonidine 100 mcg by bolus injection given by anesthesiologist in OR. intervention 6: General anesthesia given in the OR using Propofol titrated for induction. intervention 7: 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.

Protocol documents:
Prot_SAP_000.pdf: 
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