Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

• Status: Completed
• Trial end date: 2020-05-10
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Anesthetics; BB 1101; Clonidine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Epinephrine; Epinephryl borate; Propofol; Racepinephrine; Ropivacaine

Criteria

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