Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

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.

Conditions

• Malignant Neoplasms of Male Genital Organs

Interventions

PROCEDURE

Caudal Nerve Block (CNB)

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.

DRUG

Ropivacaine

Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.

DRUG

Epinephrine

Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.

DRUG

Decadron

Decadron 10 mg by bolus injection given by anesthesiologist in OR.

DRUG

Clonidine

Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.

DRUG

Propofol

General anesthesia given in the OR using Propofol titrated for induction.

BEHAVIORAL

Phone Call

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Bobby Bellard, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2020-05-10

Completion

2020-05-10

FDA Drug

Yes

Countries

• United States

Study Locations