NCT02740127 · REGISTRY CONDITION SEARCH

Evaluate Use of Caudal Nerve Blocks in Adult Penile Prosthesis

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2022-01-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)

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outcome · POSTED

Post-operative Pain the First 24hrs

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outcome · POSTED

Length of Hospital Stay

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Procedure: Caudal Nerve Block (CNB)
Drug: Ropivacaine
Drug: Epinephrine
Drug: Decadron
Drug: Clonidine
Drug: Propofol
Behavioral: Phone Call
label
Caudal Nerve Block + General Anesthesia Group
type
EXPERIMENTAL
description
Participants receive general anesthesia (GA) during surgery without a caudal nerve block. Study staff calls participant about 3 days after surgery.
intervention Names
Drug: Propofol
Behavioral: Phone Call
label
General Anesthesia Alone Group
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Caudal Nerve Block + General Anesthesia Group
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.
name
Caudal Nerve Block (CNB)
type
PROCEDURE
arm Group Labels
Caudal Nerve Block + General Anesthesia Group
description
Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.
name
Ropivacaine
other Names
Naropin
type
DRUG
arm Group Labels
Caudal Nerve Block + General Anesthesia Group
description
Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.
name
Epinephrine
type
DRUG
arm Group Labels
Caudal Nerve Block + General Anesthesia Group
description
Decadron 10 mg by bolus injection given by anesthesiologist in OR.
name
Decadron
other Names
Dexamethasone
type
DRUG
arm Group Labels
Caudal Nerve Block + General Anesthesia Group
description
Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.
name
Clonidine
type
DRUG
arm Group Labels
Caudal Nerve Block + General Anesthesia Group
General Anesthesia Alone Group
description
General anesthesia given in the OR using Propofol titrated for induction.
name
Propofol
other Names
Diprivan
type
DRUG
arm Group Labels
Caudal Nerve Block + General Anesthesia Group
General Anesthesia Alone Group
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.
name
Phone Call
type
BEHAVIORAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: SINGLE
who Masked: PARTICIPANT

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 52
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Post-Operative Pain Medication Usage in Post Anesthesia Care Unit (PACU)
time Frame
24 hours

secondary Outcomes

description
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'
measure
Post-operative Pain the First 24hrs
time Frame
24 hours
description
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.
measure
Length of Hospital Stay
time Frame
32 Hours

Full study description

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.

Source references