search
Back to results

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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EXPAREL and Local Anesthetics
Oral Opioid and Local Anesthetics
Sponsored by
Bellaire Facial Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • ClearChoice Dental Implants
  • ClearChoice Dental Implants
  • ClearChoice Dental Implants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EXPAREL and Local Anesthetics

Oral Opioid and Local Anesthetics

Arm 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).

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).

Outcomes

Primary Outcome Measures

Postsurgical Pain Severity

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2015
Last Updated
April 11, 2016
Sponsor
Bellaire Facial Surgery Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02533440
Brief Title
Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bellaire Facial Surgery Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXPAREL and Local Anesthetics
Arm Type
Experimental
Arm 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).
Arm Title
Oral Opioid and Local Anesthetics
Arm Type
Active Comparator
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
EXPAREL and Local Anesthetics
Intervention Description
Patients will receive EXPAREL and local anesthetics, as well as opioid and non-opioid analgesics prescription, (only use if needed, for post surgical pain)
Intervention Type
Procedure
Intervention Name(s)
Oral Opioid and Local Anesthetics
Intervention Description
Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)
Primary Outcome Measure Information:
Title
Postsurgical Pain Severity
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Food ingesting tolerance
Description
Ability to ingest different foods
Time Frame
7 days
Title
Analgesic medication use
Description
Analgesic medication use
Time Frame
7 days
Title
Patient Satisfaction
Description
Patient Satisfaction with pain control
Time Frame
7 days
Title
Incidence of ORAEs and other adverse events (AEs)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phil Iero, M.D., DDS
Organizational Affiliation
Primary Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
ClearChoice Dental Implants
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30305
Country
United States
Facility Name
ClearChoice Dental Implants
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
ClearChoice Dental Implants
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs