- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07246642
IPP-Platzierung & Intracavernöser Block (IPP)
Randomisierte kontrollierte Studie zur intrakorporalen Lokalanästhesie vs. Kochsalzlösung vor der Implantation einer aufblasbaren Penisprothese
The inflatable penile prosthesis (IPP) is the gold standard for surgical management of erectile dysfunction (ED) and there is no consensus on the best postoperative pain management regimen. In the wake of the opioid epidemic, postoperative pain management is heavily scrutinized. The National Institute of Health estimated over 81,000 individuals died following overdose of any opioids in 2022 alone; of these, over 14,000 deaths were linked to prescription opioids. Thus, strategies to minimize postoperative pain should not only improve patient experience but also lessen the need to escalate to opioid usage.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
It would be ideal to create an effective and easily reproducible approach to pain prevention and pain management in men undergoing IPP placement. One highly appealing target would be intracavernosal administration, as there would be no ambiguity regarding delivery of agent at the time of surgery. Thus far, no prospective randomized controlled trials have explored the efficacy of intracavernosal administration of local anesthetic for pain management.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
- Name: Sachin Vyas
- Telefonnummer: 336.713.4098
- E-Mail: Sachin.Vyas@Advocatehealth.org
Studieren Sie die Kontaktsicherung
- Name: Kimberly Waggener, MD
- Telefonnummer: 336.713.4098
- E-Mail: kimberly.waggener@advocatehealth.org
Studienorte
-
-
North Carolina
-
Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest University Health Sciences
-
Kontakt:
- Sachin Vyas
- Telefonnummer: 336-713-4098
- E-Mail: Sachin.Vyas@Advocatehealth.org
-
Kontakt:
- Kimberly Waggener, MD
- Telefonnummer: 336.713.4098
- E-Mail: kimberly.waggener@advocatehealth.org
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center
Exclusion Criteria:
- Patients undergoing revision and/or secondary IPP placement
- Patients taking prescribed narcotic medications at the time of IPP surgery
- Patients undergoing concomitant Peyronie's Disease surgery (modeling, plication, grafting) at the time of IPP surgery
- Patients with liver and/or renal disease
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Control Saline Arm
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc) |
|
|
Experimental: Exparel/bupivacaine mixture Arm
10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc) |
10cc of Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg )for total volume of 20cc into the corpora immediately prior to placement of corporotomy stay sutures.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Visual Analogue Scale (VAS) Scores
Zeitfenster: Hour 1
|
VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain. |
Hour 1
|
|
Visual Analogue Scale (VAS) Scores
Zeitfenster: Hour 4
|
VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain. |
Hour 4
|
|
Visual Analogue Scale (VAS) Scores
Zeitfenster: Hour 24
|
VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain. |
Hour 24
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cumulative Morphine milligram equivalents (MME)
Zeitfenster: Day 2
|
Cumulative morphine milligram equivalent (MME) is a metric used by healthcare providers to standardize the total potency of all opioid medications a patient is taking. By converting each opioid into a standard value based on morphine, providers can assess a patient's overall risk for overdose and other complications. Higher cumulative MME levels are associated with a greater risk of overdose. For example, doses of 50 MME or more per day increase overdose risk and warrant closer monitoring, while doses of 90 MME or more are considered very high. |
Day 2
|
|
Number of calls, messages, or visits to clinic
Zeitfenster: Day 30
|
Physician access line calls, messages to clinic, visits to clinic for postoperative pain within 30 days after surgery |
Day 30
|
|
Number of Complications
Zeitfenster: Day 30
|
Complications from intracavernosal injections |
Day 30
|
|
Number of Other Complications
Zeitfenster: Day 30
|
Other complications after IPP surgery using the Clavien-Dindo grading scale - The Clavien-Dindo scale is a grading system that categorizes surgical complications based on the treatment required to manage them, providing a uniform and objective way to assess and report post-operative events. It consists of five grades, with Grade I being minor deviations not requiring intervention and Grade V indicating patient death |
Day 30
|
|
Serum bupivacaine levels
Zeitfenster: Hours 1 and 24
|
Serum bupivacaine levels at 1 hour and 1 day after surgery - Serum bupivacaine levels are a measurement of the drug in the blood, and the "normal" or safe level varies significantly by the patient's condition, the administration site, and the dose - A 1-mL serum or plasma sample is typically collected in a red-top or green-top tube |
Hours 1 and 24
|
|
Amount of tramadol usage
Zeitfenster: Hour 24
|
Use the lowest dose possible for the shortest time needed. Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. |
Hour 24
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ryan Terlecki, MD, Wake Forest University Health Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Psychische Störungen
- Genitalerkrankungen, männlich
- Männliche Urogenitalerkrankungen
- Neurobehaviorale Manifestationen
- Sexuelle Dysfunktion, Physiologisch
- Sexuelle Dysfunktionen, Psychisch
- Wahrnehmungsstörungen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Erektile Dysfunktion
- Agnosie
Andere Studien-ID-Nummern
- IRB00129597
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
All of the Individual participant data collected during the trial, after deidentification
IPD-Sharing-Zeitrahmen
Immediately following publication - no end date
IPD-Sharing-Zugriffskriterien
anyone who wishes to access the data
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .