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

Postoperative Pain Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533440
• Other study ID #: 5142-001
• Status: Completed
• Phase: N/A
• First received: August 12, 2015
• Last updated: April 11, 2016
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Bellaire Facial Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	ClearChoice Dental Implants	Atlanta	Georgia
United States	ClearChoice Dental Implants	Houston	Texas
United States	ClearChoice Dental Implants	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bellaire Facial Surgery Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postsurgical Pain Severity		7 days	No
Secondary	Food ingesting tolerance	Ability to ingest different foods	7 days	No
Secondary	Analgesic medication use	Analgesic medication use	7 days	No
Secondary	Patient Satisfaction	Patient Satisfaction with pain control	7 days	No
Secondary	Incidence of ORAEs and other adverse events (AEs)		7 days	Yes