- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07246642
IPP-plassering & intrakavemosal blokk (IPP)
Randomisert kontrollert studie av intrakorporal lokalbedøvelse vs. salin før plassering av oppblåsbar penile protese
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Sachin Vyas
- Telefonnummer: 336.713.4098
- E-post: Sachin.Vyas@Advocatehealth.org
Studer Kontakt Backup
- Navn: Kimberly Waggener, MD
- Telefonnummer: 336.713.4098
- E-post: kimberly.waggener@advocatehealth.org
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University Health Sciences
-
Ta kontakt med:
- Sachin Vyas
- Telefonnummer: 336-713-4098
- E-post: Sachin.Vyas@Advocatehealth.org
-
Ta kontakt med:
- Kimberly Waggener, MD
- Telefonnummer: 336.713.4098
- E-post: kimberly.waggener@advocatehealth.org
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Saline Arm
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc) |
|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale (VAS) Scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cumulative Morphine milligram equivalents (MME)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 30
|
Complications from intracavernosal injections |
Day 30
|
|
Number of Other Complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ryan Terlecki, MD, Wake Forest University Health Sciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Kjønnssykdommer, mannlige
- Mannlige urogenitale sykdommer
- Nevroatferdsmanifestasjoner
- Seksuell dysfunksjon, fysiologisk
- Seksuelle dysfunksjoner, psykologiske
- Perseptuelle forstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Erektil dysfunksjon
- Agnosia
Andre studie-ID-numre
- IRB00129597
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
All of the Individual participant data collected during the trial, after deidentification
IPD-delingstidsramme
Immediately following publication - no end date
Tilgangskriterier for IPD-deling
anyone who wishes to access the data
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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