Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:June 2016
End Date:June 2021
Contact:Bobby Bellard, MD
Phone:713-794-1461

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Prospective Randomized Clinical Trial to Evaluate the Use of Caudal Nerve Blocks in Adult Penile Prosthesis Surgery

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 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.

Inclusion Criteria:

1. Patients that consent to participate.

2. Patients undergoing penile prosthesis surgery.

3. Patients that are male.

4. Patients that are 18 years of age or older.

Exclusion Criteria:

1. Patients on chronic pain medications (ie. Chronic = more than once every two days for
greater than 2 weeks) excluding Aspirin, Acetaminophen and NSAIDs.

2. Patients with a BMI > 40.

3. Patients with chronic pain syndromes.

4. Patients with hypersensitivity to Ropivacaine/amide-type anesthetics.

5. Prior surgery of the sacrum.

6. 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.

7. Patients on any anti-seizure medications, such as gabapentin or Lyrica, specifically
for chronic pain management less than 24 hours prior to surgery

8. Patients on Celebrex less than 24 hours prior to surgery

9. Patients taking more than 81 mg of Aspirin daily
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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