Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

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

Sponsors

Lead Sponsor: M.D. Anderson Cancer Center

Collaborator: Merck Sharp & Dohme Corp.

Source M.D. Anderson Cancer Center
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.

Overall Status Recruiting
Start Date 2016-06-01
Completion Date 2021-06-01
Primary Completion Date 2021-06-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU) 24 hours
Secondary Outcome
Measure Time Frame
Proportion of Participants with No Pain Immediately After Surgery 24 hours
Enrollment 104
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Caudal Nerve Block (CNB)

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.

Arm Group Label: Caudal Nerve Block + General Anesthesia Group

Intervention Type: Drug

Intervention Name: Ropivacaine

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

Arm Group Label: Caudal Nerve Block + General Anesthesia Group

Other Name: Naropin

Intervention Type: Drug

Intervention Name: Epinephrine

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

Arm Group Label: Caudal Nerve Block + General Anesthesia Group

Intervention Type: Drug

Intervention Name: Decadron

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

Arm Group Label: Caudal Nerve Block + General Anesthesia Group

Other Name: Dexamethasone

Intervention Type: Drug

Intervention Name: Clonidine

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

Arm Group Label: Caudal Nerve Block + General Anesthesia Group

Intervention Type: Drug

Intervention Name: Propofol

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

Other Name: Diprivan

Intervention Type: Behavioral

Intervention Name: Phone Call

Description: 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.

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

Gender:

Male

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Bobby Bellard, MD Principal Investigator M.D. Anderson Cancer Center
Overall Contact

Last Name: Bobby Bellard, MD

Phone: 713-794-1461

Email: [email protected]

Location
Facility: Status: University of Texas MD Anderson Cancer Center
Location Countries

United States

Verification Date

2019-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Caudal Nerve Block + General Anesthesia Group

Type: Experimental

Description: 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.

Label: General Anesthesia Alone Group

Type: Active Comparator

Description: Participants receive general anesthesia (GA) during surgery without a caudal nerve block. Study staff calls participant about 3 days after surgery.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Participant)

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