Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

January 20, 2022 updated by: M.D. Anderson Cancer Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caudal Nerve Block + General Anesthesia Group

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.
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.
Other Names:
  • Naropin
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.
Other Names:
  • Dexamethasone
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.
Other Names:
  • Diprivan
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.
Active Comparator: General Anesthesia Alone Group

Participants receive general anesthesia (GA) during surgery without a caudal nerve block.

Study staff calls participant about 3 days after surgery.
Drug: Propofol
General anesthesia given in the OR using Propofol titrated for induction.
Other Names:
  • Diprivan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
Time Frame: 24 hours
Pain evaluated by the amount of intravenous and oral pain medicine administered in the first 24 hours post-operatively. Pain assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10, where 0 is no pain and 10 is the worst pain.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain the First 24hrs
Time Frame: 24 hours
To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in decreased immediate postoperative pain in the first 24 hours after surgery compared with patients having only general anesthesia as determined by postop pain score. The mean, median and max pain will be assessed using the numeric rating scale (NRS). The NRS is scored by numeric integers, 0 through 10. The NRS will be used verbally. Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
24 hours
Length of Hospital Stay
Time Frame: 32 Hours
To determine whether the use of a CNB in patients undergoing penile prosthesis surgery results in a decreased length of hospital stay compared with patients having only general anesthesia.
32 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Bobby Bellard, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

May 10, 2020

Study Completion (Actual)

May 10, 2020

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0990
  • NCI-2016-00860 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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