Exparel 133 MG Per 10 ML Injection for Urologic Diseases

3
Effectiveness
3
Safety
Johns Hopkins Hospital, Baltimore, MD
Urologic Diseases+6 More
Exparel 133 MG Per 10 ML Injection - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Urologic Diseases

Study Summary

This study is evaluating whether a long-acting liposomal bupivacaine can reduce pain scores and reduce narcotic pain requirements in pediatric patients following minor urologic procedures.

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Eligible Conditions

  • Urologic Diseases
  • Cryptorchidism
  • Hypospadias
  • Hydrocele
  • Undescended Testis
  • Orchiectomy
  • Chordee

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

This trial is evaluating whether Exparel 133 MG Per 10 ML Injection will improve 2 primary outcomes and 3 secondary outcomes in patients with Urologic Diseases. Measurement will happen over the course of 10-14 days postoperatively.

10-14 days postoperatively
Amount of opioid medication leftover
Amount of opioid medication used post-discharge
Cumulative incidence of complications
Parents' postoperative pain measure (PPPM) scores
Percentage of patients who are opiate-free

Trial Safety

Trial Design

2 Treatment Groups

Standard 0.25% Bupivacaine
Liposomal Bupivacaine

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Exparel 133 MG Per 10 ML Injection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Liposomal Bupivacaine
Drug
Participants will receive local wound infiltration with Liposomal Bupivacaine.
Standard 0.25% Bupivacaine
Drug
Participants will receive local wound infiltration with Standard 0.25% Bupivacaine.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10-14 days postoperatively
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10-14 days postoperatively for reporting.

Closest Location

Johns Hopkins Hospital - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex of any age. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
at an ambulatory surgery center (ASC) will not be able to receive that care at an ASC if their surgery is performed on or after January 1, 2020 show original

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 are common treatments for urologic diseases?

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Most urologic diseases requiring treatment are benign and can be successfully managed with only medical care. Common treatments for a variety of urologic diseases include medications, surgery, chemotherapy, radiation, or a combination of these.

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What causes urologic diseases?

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Diabetes, hypertension, and obesity all occur and increase the likelihood of developing urologic diseases with time. This increases the likelihood of developing urogenital cancers or of developing renal, ureteral, or bladder cancer.

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Can urologic diseases be cured?

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At this time, it is impossible to cure urologic diseases by pharmacologic treatment alone. However, many urologic symptoms can be much decreased with pharmacologic remedies and procedures. A combination of medication and surgery may achieve the best results and reduce the adverse effects of those treatments.

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What is urologic diseases?

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The symptoms for the urologic diseases may be similar in all patients; some of them might lead to the erroneous diagnosis of benign pathology resulting in missed treatment of patients. Recent findings provides useful clues for diagnosis and treatment of benign urologic diseases.

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How many people get urologic diseases a year in the United States?

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Almost 8.5 million people develop renal disease and nearly 6.5 million people develop a urologic disorder. In both estimates, a significant portion of the cases will develop end-stage renal or urologic disease.

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What are the signs of urologic diseases?

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For many patients, medical symptoms are the only clinical clue that a neurological disease may be present. However, in about 10% of patients, a medical history is not adequate to make a firm diagnosis of a neurological disease, and a neurological examination is needed. In this setting, it is helpful to perform a neurological examination when the clinical history raises suspicion for a neurological disorder. These signs include changes in visual acuity and aphasia. \nClinical exam: \nChanges in the sight are the chief sign of neural damage. Loss of vision may be sudden or gradual and involve both eyes. Any sudden loss of sight should prompt thorough CNS evaluation. \nUnexplained visual loss should be investigated immediately.

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What does exparel 133 mg per 10 ml injection usually treat?

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The treatment of interstitial cystitis (IRs) with a single intravesical injection of saline solution followed by instillation of a 1:1 mixture of 1% bupivacaine with distilled water for 60 seconds can be an effective, fast-approaching, and safe intervention for IRs.

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Have there been any new discoveries for treating urologic diseases?

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Many medications and clinical applications remain in the preliminary phases of testing. A number of newer treatments for urologic conditions are in development, including a new agent in development for patients with refractory fistulae. Another promising new drug is the antiangiogenesis drug, Sutent. Clinical trials for other drugs, such as bortezomib (Velcade), may help stop tumor growth in a number of patients. There are also new studies and therapies for treating some urinary and/or urogenital cancers (e.g., bladder cancer, prostate cancer).

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What is the latest research for urologic diseases?

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Today's medicine for treating and preventing urologic diseases is new and exciting. There is a lot of new information about urologic diseases, surgical options, and treatments currently being formulated into clinical trials. Most new developments are aimed at improving patient outcomes as well as providing more choices to patients and doctors.

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Does exparel 133 mg per 10 ml injection improve quality of life for those with urologic diseases?

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Exparel 133 mg per 10 ml injection was well tolerated with no clinically significant increase in pain scores or an adverse change in continence scores. These data support the use of periurethral injection of 0.1 mL of 0.25% bupivacaine for urologic interventions that are otherwise painful.

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What is exparel 133 mg per 10 ml injection?

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There is no clear evidence that the addition of 0.33 micrograms of levobupivacaine per 10 ml increases the duration of procedural benefits that are attained with bupivacaine alone. On the other hand, the addition of levobupivacaine to the peri-operative dose of 1,8 mg per kg. is not associated with significant reductions in postoperative opioid requirements.

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What is the primary cause of urologic diseases?

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[Menstrual disorder was reported by 32% of the patients with LUTS. Other urologic disorders were the source of [prostatitis] (13%), urethral stricture (12%), and chronic pelvic pain syndrome (11%). Urologic diseases can be divided into two groups, [benign disorders] (mainly LUTS [25%]) and serious disorders (prostatitis [14%], urethral strictures [14%], [infectious urethral disease] [14%], chronic pelvic pain syndrome [14%]). The [benign bladder disorders] were associated with the highest frequency of LUTS (55%).

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