The Anesthetic and Analgesic Effect of Adjunct Liposomal Bupivacaine in Periodontal Surgical Procedures
Participants are being asked to be a part of this study because they have been scheduled to receive a gum surgery to treat periodontal (gum) disease. After agreeing to participate a pain and medication log will be provided to participants and a 5 minute survey given.
Standard of care gum surgery will be done using local anesthesia with or without intravenous sedation according to the participant's preference. If the participant is sedated, they will be asked to have an escort to take them home after the surgery as is the standard of care.
At this visit, after the surgery is complete, the doctor will inject the area next to the area that surgery was done surgery with 4 ml (about a teaspoon) of one of two solutions decided by a random 1:1 draw. The participant will receive either liposomal bupivacaine (Exparel) which is a long-acting local anesthetic or 0.5% Bupivacaine HCl with a small amount of epinephrine, a medium-acting dental anesthetic.
After surgery, as standard of care, participants will be given instructions on taking over-the-counter medications as needed for pain.
Participants will be asked to fill out the pain survey and tablet log at specific times after leaving the clinic.
A standard of care follow-up visit with the doctor will be scheduled about 2 weeks after the surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A randomized, double blinded clinical trial investigating the analgesic and anesthetic effect of liposomal bupivacaine when used after periodontal surgical procedures in addition to standard of care provided local anesthesia. These parameters will be compared to a control group that will receive 0.5% bupivacaine after completion of the procedure during which standard of care local anesthesia will be used.
Primary Objective:
Postoperative pain as measured with a Visual Acuity Scale (VAS) (NRS-21)
Secondary Objectives:
- Time (hours/minutes) for numbness due to local anesthetic to wear off
- Number of tablets of ibuprofen and acetaminophen consumed
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Texas
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San Antonio, Texas, États-Unis, 78229
- University of Texas Health Science Center at San Antonio
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 18 to 89 years old
- Require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures
- In either the maxillary or mandibular arch.
Exclusion Criteria:
- Pregnancy, or those planning to become pregnant
- Allergy or any medical issue using Bupivacaine
- Inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
- Non-English speaking
- Patients requiring narcotic medications for IV sedation
- Patients requiring either IV or oral steroids during the perioperative period
- Patients with liver 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 |
|---|---|
|
Expérimental: Adjunctive long acting local anesthesia post surgery
The experimental group will receive a longer lasting formulation of bupivacaine (liposomal bupivacaine) as an adjunctive local infiltration
|
4 ml of Liposomal bupivacaine 13.3 mg/ml is injected adjacent to the surgical site post-surgery
|
|
Comparateur actif: Adjunctive standard of care local anesthetic
The control group will receive a commonly used in dentistry local anesthetic (0.5% bupivacaine HCL) as an adjunctive analgesic after the end of the procedure.
|
4 ml of bupivacaine 0.5% will be injected adjacent to the surgical site post-surgery
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post-operative pain measured with Numeric Rating Scale NRS-21 pain scale
Délai: 3 to 168 hours
|
Pain perceived at regular time intervals using a Visual Analogue Scale (NRS-21) rating their pain at specific time points on a scale from 0 to 10 with 0.5 points in between.
A higher score indicates more pain.
|
3 to 168 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time for numbness to wear off
Délai: 3 to 168 hours
|
Amount of time in hours/minutes for numbness due to local anesthetic to wear off
|
3 to 168 hours
|
|
Number of of anti-inflammatory tablets taken
Délai: Baseline to 7 days
|
Number of ibuprofen/Motrin tablets taken post surgery
|
Baseline to 7 days
|
|
Number of analgesic tablets taken
Délai: Baseline to 7 days
|
Number of acetaminophen tablets taken post surgery
|
Baseline to 7 days
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00000764
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
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.
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