Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis
Condition: Malignant Neoplasms of Male Genital Organs
MeSH terms: Neoplasms; Genital Neoplasms, Male
Intervention: Caudal Nerve Block (CNB); Ropivacaine; Epinephrine; Decadron; Clonidine; Propofol; Phone Call
Intervention description: 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.
Intervention MeSH terms: Dexamethasone; Clonidine; Epinephrine; Propofol; Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 52.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility 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