Postoperative PainPhase 1EBPEANCT03268278
Efficacy of Buprenorphine on Postoperative Endodontic Analgesia
A Phase 1 study testing Buprenorphine, Sterile saline and lidocaine, epinephrine (Local anesthetic) in people with Postoperative Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain 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?
- Buprenorphine, Sterile saline and lidocaine, epinephrine (Local anesthetic)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 1 Jul 2018
- Phase
- Phase 1
- 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
- persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered
Who cannot join
- pregnancy, allergy to buprenorphine, allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain
- Conditions
- Postoperative Pain
- Being tested
- Buprenorphine, Sterile saline, lidocaine, epinephrine (Local anesthetic)
- Keywords
- analgesia, endodontic, postoperative
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Buprenorphine plus local anesthetic
Sterile salineDrug
Placebo 1,8 ml
lidocaine, epinephrine (Local anesthetic)Drug
2% lidocaine 1:100,000 epinephrine
| Study group | Role | What they receive |
|---|---|---|
| buprenorphine and local anesthetic | Active comparator | buprenorphine added to local anesthetic Receives: Drug: Buprenorphine; Drug: lidocaine, epinephrine (Local anesthetic) |
| sterile saline and local anesthetic | Placebo comparator | sterile saline (placebo) added to local anesthetic Receives: Drug: Sterile saline; Drug: lidocaine, epinephrine (Local anesthetic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Apr 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Loss of interest
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.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas A. Montagnese, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268278
- Sponsor's protocol ID
- UHClevelandMCBupStudy
- Acronym
- EBPEA
- Status last verified
- Apr 2019
- First submitted
- 11 Aug 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Buprenorphine on Postoperative Endodontic Analgesia
- ClinicalTrials.gov ID
- NCT03268278
- Acronym / sponsor ID
- EBPEA / UHClevelandMCBupStudy
- Conditions
- Postoperative Pain
- Keywords
- analgesia, endodontic, postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of interest
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- 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.
To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buprenorphine and local anesthetic | Active comparator | Drug: Buprenorphine, Drug: lidocaine, epinephrine (Local anesthetic)buprenorphine added to local anesthetic |
| sterile saline and local anesthetic | Placebo comparator | Drug: Sterile saline, Drug: lidocaine, epinephrine (Local anesthetic)sterile saline (placebo) added to local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered
Key exclusion criteria (1 listed)
- pregnancy, allergy to buprenorphine, allergy to local anesthetic
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 |
|---|---|---|
| BuprenorphineBuprenorphine plus local anesthetic | Drug | buprenorphine and local anesthetic |
| Sterile salinePlacebo 1,8 ml | Drug | sterile saline and local anesthetic |
| lidocaine, epinephrine (Local anesthetic)2% lidocaine 1:100,000 epinephrine | Drug | buprenorphine and local anesthetic, sterile saline and local anesthetic |
Primary outcome
The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
Time frame: two years
The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data.
Results and safety
The study was stopped early (reason given: Loss of interest). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Buprenorphine, Sterile saline and lidocaine, epinephrine (Local anesthetic) in people with Postoperative Pain, run by University Hospitals Cleveland Medical Center at 1 site 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Loss of interest). Results are not available in the source record.
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?
The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia (time frame: two years). 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 23 Apr 2019.