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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Oral Opioid and Local Anesthetics; Procedure: EXPAREL and Local Anesthetics

• Registration Number: NCT02533440
• Lead Sponsor: Bellaire Facial Surgery Center

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-26
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Opioid and Local Anesthetics	Oral Opioid and Local Anesthetics	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).
EXPAREL and Local Anesthetics	EXPAREL and Local Anesthetics	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).

Primary Outcome Measures

Name	Time	Method
Postsurgical Pain Severity	7 days

Secondary Outcome Measures

Name	Time	Method
Analgesic medication use	7 days	Analgesic medication use
Incidence of ORAEs and other adverse events (AEs)	7 days
Food ingesting tolerance	7 days	Ability to ingest different foods
Patient Satisfaction	7 days	Patient Satisfaction with pain control

Trial Locations

Locations (1)

ClearChoice Dental Implants; 🇺🇸 The Woodlands, Texas, United States