Randomization of two local anesthetics. for Erectile Dysfunction

Phase-Based Estimates
3
Effectiveness
3
Safety
Mayo Clinic in Rochester, Rochester, MN
Erectile Dysfunction
Randomization of two local anesthetics. - Procedure
Eligibility
18+
Male
Eligible conditions
Erectile Dysfunction

Study Summary

This study is evaluating whether a new type of anesthesia may help reduce pain for individuals who are having surgery for a penile prosthesis.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Randomization of two local anesthetics. will improve 4 primary outcomes in patients with Erectile Dysfunction. Measurement will happen over the course of post-operative day 14.

post-operative day 14
Pain Catastrophizing scale
State Trait Anxiety Inventory
Visual-analogue anxiety scale
Visual-analogue pain scale

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Receiving Ropivacaine

This trial requires 130 total participants across 2 different treatment groups

This trial involves 2 different treatments. Randomization Of Two Local Anesthetics. is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Receiving Ropivacaine
Procedure
Patients receiving Ropivacaine.
Receiving Liposomal Bupivacaine
Procedure
Patients receiving Liposomal Bupivacaine.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-operative day 14
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post-operative day 14 for reporting.

Who is running the study

Principal Investigator
M. (. J. Z.
Matthew (Matt) J. Ziegelmann, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Current or prior history of alcohol or drug abuse (illicit or prescription)
Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
≥ 18 years old.
History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review)
History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.)
History of cardiac arrhythmia or untreated severe cardiovascular disease
Uncontrolled hypertension
Hepatic insufficiency
Renal insufficiency (CKD stage IIIa or greater)
Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is erectile dysfunction?

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Erectile dysfunction (ED) is a persistent and significant problem in men and affects their sexual and marital relationships, quality of life and mood. ED affects men of all ages and is an important reason for men to seek help. Erectile dysfunction is not a single entity, and as such it is best seen as a spectrum of ED.

Unverified Answer

What are common treatments for erectile dysfunction?

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Erectile dysfunction is common, especially for males 40 and above. The majority of patients have problems locating the source of their erectile dysfunction. The most common treatments are medications to treat testosterone levels. It is important to understand this, as well as the benefits and adverse effects of these medications. If medication isn’t appropriate, then a variety of other treatments may be tried, including lifestyle changes and physical therapy.\n

Unverified Answer

Can erectile dysfunction be cured?

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ED in women is difficult to treat. Surgical correction of ED may not be a cure, but patients can be cured on a daily basis. ED can be a very important aspect of relationships as it has implications on the level of acceptance and confidence in relationships. The authors consider that surgical correction is a crucial prerequisite to successful treatment, and the level of self-confidence can be restored.

Unverified Answer

What causes erectile dysfunction?

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The most relevant contributing factors seem to be age, smoking, diabetes (diabetes mellitus), and cardiovascular disease. The most important risk factor is diabetes mellitus, where the incidence of erectile dysfunction was found to be 17.4%. Diabetes mellitus is not only a risk factor for the onset of erectile dysfunction, but is also related with the pathogenesis of the disease; this fact makes diabetes management of utmost importance. Other major risk factors are aging and hypertension.

Unverified Answer

How many people get erectile dysfunction a year in the United States?

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Although rates of ED have increased during the last three decades, most men reporting ED are satisfied with their sexual lives. Nevertheless, many men experience sexual distress relating to ED. Male infertility remains a problem for some men.

Unverified Answer

What are the signs of erectile dysfunction?

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A penile exam is the best non-invasive test for ED, with a sensitivity of 80%. EFT for ED: penile cavernous pressure of >15 cm H2O, NICE, and NIH. Penile curvature of >30 degrees is uncommon in the normal ED population. If the ED patient has a penis that is shorter than standard, further imaging should be contemplated.

Unverified Answer

How serious can erectile dysfunction be?

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Patients' erectile quality is associated with baseline ED, age, and comorbidities; most penile quality changes for all patients between baseline and 48-hour post-treatment change in Penile Qualty (PQ) score. Age is associated with baseline QoL and change.

Unverified Answer

Who should consider clinical trials for erectile dysfunction?

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Based on the available evidence, trials for therapeutic interventions are a potential research tool for the treatment of erectile dysfunction of psychogenic and organic origin. However, the present studies are too limited for definite conclusions. More detailed and systematic studies on the therapeutic interventions of erectile dysfunction must be undertaken in the future.

Unverified Answer

Have there been any new discoveries for treating erectile dysfunction?

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There have been many discoveries in penis surgery, and some of them were helpful for patients with erectile dysfunction. However, there was not enough evidence about the efficacy of such surgeries for this purpose, which makes it urgent for scientists to keep looking for a better way to treat erectile dysfunction. In addition, there are no satisfactory treatments for chronic erectile dysfunction, although some patients have reported improvements using penile implants and penile injections after the surgical intervention.

Unverified Answer

What are the latest developments in randomization of two local anesthetics. for therapeutic use?

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The latest development is local anesthetic infiltration of the penis, which can be performed in real time in the operating room before performing a radical prostatectomy. The process appears safe and easy, but is yet to be tried by general surgeons.

Unverified Answer

How does randomization of two local anesthetics. work?

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To prevent bias related to randomness, we should not use a technique, which gives each patient his own name for the anesthetic, because one could then imagine that the effect of the anesthetic is lessened, or disappears completely, when the name of the anesthetic that is to be used is known to the physician. Because of this, we should use the randomization technique which consists in giving each patient two tablets of anesthetics, which are equally used and have similar potency in anesthetizing.

Unverified Answer

Is randomization of two local anesthetics. safe for people?

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Two local anesthetics in concentrations and amounts that are acceptable for local anesthesia do not produce any clinically significant interaction. Local anesthetics are considered safe when used at the local skin concentration and in a concentration of 1.5% to 2%, which in our case is 1 to 1.6% in which the concentration in the lidocaine solution is about 10 to 11% of the volume of the solution. Local anesthetics are considered safe when a short local anesthetic time may be used.

Unverified Answer
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