Postoperative PainFASTNCT02533440
Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain
A study testing EXPAREL and Local Anesthetics and Oral Opioid and Local Anesthetics in people with Postoperative Pain, run by Bellaire Facial Surgery Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- EXPAREL and Local Anesthetics and Oral Opioid and Local Anesthetics
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ClearChoice Dental Implants
Atlanta, Georgia, 30305
ClearChoice Dental Implants
Houston, Texas, 77024
ClearChoice Dental Implants
The Woodlands, Texas, 77380
About this study
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
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.
Read the 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
- Being tested
- EXPAREL and Local Anesthetics, Oral Opioid and Local Anesthetics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPAREL and Local AnestheticsProcedure or surgery
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 AnestheticsProcedure or surgery
Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Oral Opioid and Local Anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postsurgical Pain Severity
Measured: 7 days
Secondary outcomes (4)
Food ingesting tolerance
Ability to ingest different foods
Measured: 7 days
Analgesic medication use
Analgesic medication use
Measured: 7 days
Patient Satisfaction
Patient Satisfaction with pain control
Measured: 7 days
Incidence of ORAEs and other adverse events (AEs)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellaire Facial Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip T. Iero, Bellaire Facial Surgery Center
- Investigators
- Phil Iero, M.D., DDS, Principal investigator, Primary Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533440
- Sponsor's protocol ID
- 5142-001
- Acronym
- FAST
- Status last verified
- Apr 2016
- First submitted
- 12 Aug 2015
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02533440
- Acronym / sponsor ID
- FAST / 5142-001
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Bellaire Facial Surgery CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPAREL and Local Anesthetics | Experimental | Procedure: EXPAREL and Local AnestheticsIn 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 | Procedure: Oral Opioid and Local AnestheticsIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPAREL and Local AnestheticsPatients will receive EXPAREL and local anesthetics, as well as opioid and non-opioid analgesics prescription, (only use if needed, for post surgical pain) | Procedure or surgery | EXPAREL and Local Anesthetics |
| Oral Opioid and Local AnestheticsPatients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain) | Procedure or surgery | Oral Opioid and Local Anesthetics |
Primary outcome
Postsurgical Pain Severity
Time frame: 7 days
4 secondary outcomes
Food ingesting tolerance
Time frame: 7 days
Analgesic medication use
Time frame: 7 days
Patient Satisfaction
Time frame: 7 days
Incidence of ORAEs and other adverse events (AEs)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Iero, M.D., DDS principal investigator
Primary Investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXPAREL and Local Anesthetics and Oral Opioid and Local Anesthetics in people with Postoperative Pain, run by Bellaire Facial Surgery Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postsurgical Pain Severity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.