Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain (FAST)

Bellaire Facial Surgery Center

Status: Completed

Conditions: Postoperative Pain

Treatments: Procedure: EXPAREL and Local Anesthetics; Procedure: Oral Opioid and Local Anesthetics

Study type: Interventional

Funder types: Other

Identifiers

NCT02533440

5142-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

EXPAREL and Local Anesthetics

Experimental group

Description:

In the experimental group, patients will receive EXPAREL and local anesthetics, and will be prescribed opioid and non-opioid analgesics (for use only if in pain).

Treatment:

Procedure: EXPAREL and Local Anesthetics

Oral Opioid and Local Anesthetics

Active Comparator group

Description:

In the control group, patients will receive local anesthetics at the time of surgery and oral opioid or non-opioid analgesics (for use only if in pain).

Treatment:

Procedure: Oral Opioid and Local Anesthetics