Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postsurgical Pain Severity | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Food ingesting tolerance | Ability to ingest different foods | 7 days |
| Analgesic medication use | Analgesic medication use | 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Phil Iero, M.D., DDS | Primary Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClearChoice Dental Implants | Atlanta | Georgia | 30305 | United States | ||
| ClearChoice Dental Implants |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
|
| Patient Satisfaction | Patient Satisfaction with pain control | 7 days |
| Incidence of ORAEs and other adverse events (AEs) | 7 days |
| Houston |
| Texas |
| 77024 |
| United States |
| ClearChoice Dental Implants | The Woodlands | Texas | 77380 | United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D009294 | Narcotics |
| D000700 | Analgesics |
Not provided
Not provided