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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Patients will receive EXPAREL and local anesthetics, as well as opioid and non-opioid analgesics prescription, (only use if needed, for post surgical pain)
Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)
ClearChoice Dental Implants
Atlanta, Georgia, United States
ClearChoice Dental Implants
Houston, Texas, United States
ClearChoice Dental Implants
The Woodlands, Texas, United States
Postsurgical Pain Severity
Time frame: 7 days
Food ingesting tolerance
Ability to ingest different foods
Time frame: 7 days
Analgesic medication use
Analgesic medication use
Time frame: 7 days
Patient Satisfaction
Patient Satisfaction with pain control
Time frame: 7 days
Incidence of ORAEs and other adverse events (AEs)
Time frame: 7 days
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