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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: EXPAREL and Local Anesthetics; Procedure: Oral Opioid and Local Anesthetics

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • ClearChoice Dental Implants
  • Texas
    • Houston, Texas, United States, 77024
      • ClearChoice Dental Implants
    • The Woodlands, Texas, United States, 77380
      • ClearChoice Dental Implants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: EXPAREL 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)
Active Comparator: 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).	Procedure: Oral 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postsurgical Pain Severity	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bellaire Facial Surgery Center
• Investigators: Principal Investigator: Phil Iero, M.D., DDS, Primary Investigator

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Estimate): April 13, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 5142-001