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

NCT ID: NCT02533440

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

EXPAREL and Local Anesthetics

Intervention Type: PROCEDURE

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

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).

Group Type: ACTIVE_COMPARATOR

Oral Opioid and Local Anesthetics

Intervention Type: PROCEDURE

Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bellaire Facial Surgery Center

OTHER

Sponsor Role: lead

Responsible Party

Phillip T. Iero

Oral Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phil Iero, M.D., DDS

Role: PRINCIPAL_INVESTIGATOR

Primary Investigator

Locations

ClearChoice Dental Implants

Atlanta, Georgia, United States

ClearChoice Dental Implants

Houston, Texas, United States

ClearChoice Dental Implants

The Woodlands, Texas, United States

Countries

United States

Other Identifiers

5142-001

Identifier Type: -

Identifier Source: org_study_id