- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07246642
Placement de PPI et Bloc Intracavernaux (IPP)
Essai contrôlé randomisé de l'anesthésie locale intracorporelle vs solution saline avant la pose de prothèse pénienne gonflable
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sachin Vyas
- Numéro de téléphone: 336.713.4098
- E-mail: Sachin.Vyas@Advocatehealth.org
Sauvegarde des contacts de l'étude
- Nom: Kimberly Waggener, MD
- Numéro de téléphone: 336.713.4098
- E-mail: kimberly.waggener@advocatehealth.org
Lieux d'étude
-
-
North Carolina
-
Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences
-
Contact:
- Sachin Vyas
- Numéro de téléphone: 336-713-4098
- E-mail: Sachin.Vyas@Advocatehealth.org
-
Contact:
- Kimberly Waggener, MD
- Numéro de téléphone: 336.713.4098
- E-mail: kimberly.waggener@advocatehealth.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Saline Arm
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc) |
|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analogue Scale (VAS) Scores
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cumulative Morphine milligram equivalents (MME)
Délai: 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
Délai: 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
Délai: Day 30
|
Complications from intracavernosal injections |
Day 30
|
|
Number of Other Complications
Délai: 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
|
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Serum bupivacaine levels
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ryan Terlecki, MD, Wake Forest University Health Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Manifestations neurologiques
- Maladies du système nerveux
- Les troubles mentaux
- Maladies génitales, sexe masculin
- Maladies urogénitales masculines
- Manifestations neurocomportementales
- Dysfonction sexuelle, physiologique
- Dysfonctions sexuelles, psychologiques
- Troubles de la perception
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Dysérection
- Agnosie
Autres numéros d'identification d'étude
- IRB00129597
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
All of the Individual participant data collected during the trial, after deidentification
Délai de partage IPD
Immediately following publication - no end date
Critères d'accès au partage IPD
anyone who wishes to access the data
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .