Postoperative Pain
Conditions
Brief summary
This study is researching managing postsurgical pain by injecting both short-acting local anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or eliminate the need for postsurgical opioids and improve clinical outcomes following the FAST dental implant surgery procedure. This approach is being compared to the current standard of care.
Detailed description
Postsurgical pain following the Full Arch Surgical Therapy (FAST) dental implant surgery procedure is commonly managed with a variety of interventions, including local infiltration with short-acting local anesthetics during surgery and the use of postsurgical opioid and non-opioid analgesics. Although this approach to managing postsurgical pain is considered the current standard of care, its reliance on opioid analgesics to provide analgesia beyond the duration of short-acting local anesthetics exposes patients to opioid-related adverse events (ORAEs) that may delay their recovery and have other deleterious clinical consequences. The primary objective of this study is to determine the efficacy and safety of local infiltration of EXPAREL for the FAST dental implant surgery procedure compared to standard of care.
Interventions
PROCEDUREEXPAREL and Local Anesthetics
Patients will receive EXPAREL and local anesthetics, as well as opioid and non-opioid analgesics prescription, (only use if needed, for post surgical pain)
PROCEDUREOral Opioid and Local Anesthetics
Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)
Sponsors
Bellaire Facial Surgery Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older; * Ability to speak, read, and write in English; * Ability to communicate via telephone; * Scheduled to undergo FAST dental implant surgery procedure at a study center within the next 30 days for both maxillary and mandibular repair with at least 4 upper and 4 lower teeth to be extracted; * Willing to provide informed consent, participate in study, and comply with study protocol.
Exclusion criteria
* Daily opioid consumption for more than 30 days prior to surgery; * Any opioid consumption within 3 days prior to surgery. * Prior treatment for alcohol, recreational drug, or opioid abuse. * Hypersensitivity or allergy to local anesthetics, non steroidal anti-inflammatory drugs, or opioids; * Breastfeeding, pregnant, or contemplating pregnancy prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postsurgical Pain Severity | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food ingesting tolerance | 7 days | Ability to ingest different foods |
| Analgesic medication use | 7 days | Analgesic medication use |
| Patient Satisfaction | 7 days | Patient Satisfaction with pain control |
| Incidence of ORAEs and other adverse events (AEs) | 7 days | — |
Countries
United States
Outcome results
None listed