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

NCT02533440 | Completed

• 1 other identifier: 5142-001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postsurgical Pain Severity

  7 days

Secondary Outcomes (4)

• Food ingesting tolerance

  7 days

• Analgesic medication use

  7 days

• Patient Satisfaction

  7 days

• Incidence of ORAEs and other adverse events (AEs)

  7 days

Study Arms (2)

EXPAREL and Local Anesthetics

EXPERIMENTAL

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

Oral Opioid and Local Anesthetics

ACTIVE COMPARATOR

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

Interventions

EXPAREL and Local Anesthetics 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)

EXPAREL and Local Anesthetics

Oral Opioid and Local Anesthetics PROCEDURE

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

Oral Opioid and Local Anesthetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bellaire Facial Surgery Center: lead

Study Sites (3)

ClearChoice Dental Implants

Atlanta, Georgia, 30305, United States

Location

ClearChoice Dental Implants

Houston, Texas, 77024, United States

Location

ClearChoice Dental Implants

The Woodlands, Texas, 77380, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, Local; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Narcotics; Analgesics

Study Officials

• Phil Iero, M.D., DDS

  Primary Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral Surgeon

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

US (3)