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Local Anesthetic
Exparel + Ropivacaine for Post-Surgery Pain in Erectile Dysfunction
Phase 4
Waitlist Available
Led By Matthew J Ziegelmann, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 14
Awards & highlights
Study Summary
This trial is testing whether penile ring block using a mix of liposomal bupivacaine and ropivacaine is more effective than using ropivacaine alone for local anesthesia during surgery for penile prosthesis placement.
Who is the study for?
Men over 18 undergoing their first penile prosthesis surgery at Mayo Clinic - Rochester can join. They must be under general anesthesia and not have used opioids in the last 90 days. They're ineligible if they have liver or serious kidney issues, are on certain blood thinners, have uncontrolled diabetes (HgbA1c > 8.5), plan other surgeries at the same time, use non-general anesthesia, abuse substances, have severe heart problems or chronic pain conditions.Check my eligibility
What is being tested?
The study is testing two local anesthetics for post-surgery pain control in men getting penile implants: liposomal bupivacaine versus ropivacaine mixture. Patients will randomly receive one of these to see which is more effective for pain management after surgery.See study design
What are the potential side effects?
Possible side effects from the anesthetics may include allergic reactions, nerve damage leading to numbness or weakness, low blood pressure, nausea or vomiting. The severity and occurrence of side effects can vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Catastrophizing scale
State Trait Anxiety Inventory
Visual-analogue anxiety scale
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Receiving RopivacaineExperimental Treatment1 Intervention
Patients receiving Ropivacaine.
Group II: Receiving Liposomal BupivacaineExperimental Treatment1 Intervention
Patients receiving Liposomal Bupivacaine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Randomization of two local anesthetics.
2021
Completed Phase 4
~20
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,120 Total Patients Enrolled
6 Trials studying Erectile Dysfunction
104 Patients Enrolled for Erectile Dysfunction
Matthew J Ziegelmann, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of heart rhythm problems or untreated serious heart conditions.Your high blood pressure is not well controlled.You have previously undergone surgery to repair or replace a penile prosthesis.You have a history of long-lasting pain conditions like chronic musculoskeletal pain, fibromyalgia, or chronic pelvic pain syndrome.You have had an allergic reaction or bad experience with any of the local anesthetic drugs used in the study.You have previously had surgery to implant a penile prosthesis or an artificial urinary sphincter.You have a history of using alcohol or drugs in a harmful or addictive way.
Research Study Groups:
This trial has the following groups:- Group 1: Receiving Ropivacaine
- Group 2: Receiving Liposomal Bupivacaine
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the randomization of two local anesthetics sanctioned by the FDA?
"The safety profile of this randomization trial involving two local anesthetics has been established through Phase 4 trials, and thus we have assigned it a score of 3."
Answered by AI
How many people are taking part in this research endeavor?
"Affirmative. The clinicaltrials.gov website states that this research project, initially made available on October 1st 2021, is still seeking participants. Approximately 130 volunteers are required from 1 medical center."
Answered by AI
Are any new participants being accepted into this research endeavor at the moment?
"Affirmative. According to clinicaltrials.gov, the trial which was first advertised on October 1st 2021 is in search of participants at this moment. As of May 16th 2022, it requires 130 people from a single medical facility for completion."
Answered by AI
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