- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07246642
IPP-placering & Intracavernös block (IPP)
Randomiserad kontrollerad studie av intracorporal lokalbedövning jämfört med koksaltlösning före placering av inflaterbar penilprotes
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Sachin Vyas
- Telefonnummer: 336.713.4098
- E-post: Sachin.Vyas@Advocatehealth.org
Studera Kontakt Backup
- Namn: Kimberly Waggener, MD
- Telefonnummer: 336.713.4098
- E-post: kimberly.waggener@advocatehealth.org
Studieorter
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Health Sciences
-
Kontakt:
- Sachin Vyas
- Telefonnummer: 336-713-4098
- E-post: Sachin.Vyas@Advocatehealth.org
-
Kontakt:
- Kimberly Waggener, MD
- Telefonnummer: 336.713.4098
- E-post: kimberly.waggener@advocatehealth.org
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control Saline Arm
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc) |
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue Scale (VAS) Scores
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cumulative Morphine milligram equivalents (MME)
Tidsram: 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
Tidsram: 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
Tidsram: Day 30
|
Complications from intracavernosal injections |
Day 30
|
|
Number of Other Complications
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Ryan Terlecki, MD, Wake Forest University Health Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Mentala störningar
- Genitala sjukdomar, manliga
- Manliga urogenitala sjukdomar
- Neurobehavioral manifestationer
- Sexuell dysfunktion, fysiologisk
- Sexuella dysfunktioner, psykologiska
- Perceptuella störningar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Erektil dysfunktion
- Agnosia
Andra studie-ID-nummer
- IRB00129597
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
All of the Individual participant data collected during the trial, after deidentification
Tidsram för IPD-delning
Immediately following publication - no end date
Kriterier för IPD Sharing Access
anyone who wishes to access the data
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
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