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Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement

5 juin 2018 mis à jour par: charbel salamon, Atlantic Health System

Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial

Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups. One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a prospective, comparative, randomized study. Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups. The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution. The postoperative pain will be compared between groups using a visual analog scale. The quality of recovery will be compared between the groups using the quality of recovery short form. Postoperative opioid consumption will be compared between the two groups.

Type d'étude

Interventionnel

Inscription (Réel)

57

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New Jersey
      • Morristown, New Jersey, États-Unis, 07960
        • Morrristown Medical Center
      • Summit, New Jersey, États-Unis, 07901
        • Overlool Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

19 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • ASA physical status I-III
  • Age >18 years
  • Not Pregnant
  • Able to give informed consent
  • Electively chose surgical management of SUI with a suburethral sling

Exclusion Criteria:

  • Pregnant or nursing
  • Allergy to amide anesthetics
  • History of drug or alcohol abuse
  • Severe cardiovascular, hepatic, renal disease or neurological impairment,
  • Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
  • Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
  • Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine,
  • Administration of an investigational drug within 30 days before this study
  • Chronic pain syndromes
  • Daily NSAID or opioid use
  • Patients undergoing concomitant procedures

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Liposomal Bupivacaine
20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
Médicament: Liposomal Bupivacaine
20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars
Autres noms:
  • EXPARER
Procédure: Suburethral Sling
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Autres noms:
  • Midurethral Sling
Comparateur actif: Bupivacaine Hydrochloride and Lidocaine
Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
Procédure: Suburethral Sling
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Autres noms:
  • Midurethral Sling
Médicament: Bupivacaine Hydrochloride and Lidocaine
Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
Autres noms:
  • Marcaine and Lidocaine

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postoperative Day 1 Pain
Délai: Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm. This will be recorded by the patient prior to going to bed.
Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Second Stage PACU Postoperative Pain
Délai: The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.
Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU.
The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.
Postoperative Pain Upon Discharge
Délai: The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.
Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital.
The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.
Postoperative Pain Four Hours After Discharge
Délai: Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced. This will be recorded 4 hours after being discharged from the hospital.
Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Night of Surgery Postoperative Pain
Délai: Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery.
Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Postoperative Days 2 through 7 Pain
Délai: Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7.
Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Preoperative Quality of Recovery
Délai: The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.
The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
Postoperative Days 1, 7 and 14 Quality of Recovery
Délai: The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.
The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Postoperative Narcotic Consumption
Délai: The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed.
The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Atlantic Health System

Les enquêteurs

  • Chercheur principal: Charbel Salamon, MD, Atlantic Health System

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2016

Achèvement primaire (Réel)

1 mai 2018

Achèvement de l'étude (Réel)

1 mai 2018

Dates d'inscription aux études

Première soumission

27 juin 2016

Première soumission répondant aux critères de contrôle qualité

17 août 2016

Première publication (Estimation)

23 août 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juin 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2018

Dernière vérification

1 juin 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 883788-1

Plan pour les données individuelles des participants (IPD)

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NON

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 .

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