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

• Sponsor: Bellaire Facial Surgery Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02533440
• Collaborator: (none)
• Enrollment: 69
• Locations: 3
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 23
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: EXPAREL and Local Anesthetics; Procedure: Oral Opioid and Local Anesthetics	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Postsurgical Pain Severity [7 days]

Secondary Outcome Measures

1. Food ingesting tolerance [7 days]

   Ability to ingest different foods

2. Analgesic medication use [7 days]

   Analgesic medication use

3. Patient Satisfaction [7 days]

   Patient Satisfaction with pain control

4. Incidence of ORAEs and other adverse events (AEs) [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ClearChoice Dental Implants	Atlanta	Georgia	United States	30305
2	ClearChoice Dental Implants	Houston	Texas	United States	77024
3	ClearChoice Dental Implants	The Woodlands	Texas	United States	77380

Sponsors and Collaborators

• Bellaire Facial Surgery Center

Investigators

• Principal Investigator: Phil Iero, M.D., DDS, Primary Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phillip T. Iero, Oral Surgeon, Bellaire Facial Surgery Center
• ClinicalTrials.gov Identifier: NCT02533440
• Other Study ID Numbers: 5142-001
• First Posted: Aug 26, 2015
• Last Update Posted: Apr 13, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Pain, Postoperative; Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Apr 13, 2016