Clinical trial NCT02533440: Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain
Official title: A Prospective, Randomized, Open-Label Study Comparing Postsurgical Analgesia Using EXPAREL® To Standard Of Care For The Full Arch Surgical Therapy (FAST) Dental Implant Surgery Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Bellaire Facial Surgery Center
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postsurgical Pain Severity
timeFrame: 7 days
Secondary outcomes:
measure: Food ingesting tolerance
timeFrame: 7 days
measure: Analgesic medication use
timeFrame: 7 days
measure: Patient Satisfaction
timeFrame: 7 days
measure: Incidence of ORAEs and other adverse events (AEs)
timeFrame: 7 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: ClearChoice Dental Implants
state: Georgia
city: Houston
country: United States
facility: ClearChoice Dental Implants
state: Texas
city: The Woodlands
country: United States
facility: ClearChoice Dental Implants
state: Texas
Study officials:
affiliation: Primary Investigator
name: Phil Iero, M.D., DDS
role: PRINCIPAL_INVESTIGATOR
References: