PainPhase 2BADDAPNCT04207411
Efficacy of Repeated Locoregional Anesthetics Blocks With Bupivacaine in Patients Suffering of Chronic Dentoalveolar Pain.
A Phase 2 study testing Bupivacaine and Lidocaine in people with Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to evaluate the efficacy of anesthetic blocks repeated with bupivacaine in the management of patients with persistent dentoalveolar pain. Goals are to improve the understanding of the physiopathological mechanisms of persistent dentoalveolar pain and to highlight predictive criteria for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Aug 2020to Oct 2023
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, over 18, with persistent dentoalveolar pain defined according to the criteria:
- daily presence (> 2 hours / day and for more than 3 months) and continues pain;
- located at one or more teeth or at the level of the alveolar bone;
- not following a nervous path;
- clinical, radiological and neurological examinations showing no cause organic visible;
- dental causes excluded by appropriate tests;
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- local or systemic pathologies related to pain apart.
- Pain intensity greater than or equal to 4/10 on numerical scale
- Patient informed of the constraints of the study and having given his written consent. Benefiting of a social security scheme.
- Mastering correctly French.
Who cannot join
- Pregnant women, breastfeeding, or likely to be pregnant.
- Oral pain of known origin (cancerous, infectious, traumatic).
- Patient having modified (stopped, started or modified dosage) in the last 2 month local or systemic medication that may interfere with the study results (for example, patients taking long-range psychotropic drugs will not be excluded).
- All medical pathology judged by the investigator as not compatible with the study.
- Known hypersensitivity to local amide-bound anesthetics or to any of the excipients
- Treatment anticoagulant or known disorder of blood
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- Porphyria.
- Atrioventricular conduction requiring training permanent electrosystol not yet realized.
- Epilepsy not controlled by a treatment.
- Patient non-cooperating, not speaking or not reading fluently French or in the impossibility of understanding the principle of a pain scale or understanding the study or to sign an informed consent.
- Patient under guardianship, curatorship, or deprived of liberties.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, Pharm D, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Céline MELIN, BDS, PhD
About this study
Official title: Efficacy of Repeated Locoregional Anesthetics Blocks With Bupivacaine in Patients Suffering of Chronic Dentoalveolar Pain. (BADDAP)
The aim of this study is to evaluate the efficacy of anesthetic blocks repeated with bupivacaine in the management of patients with persistent dentoalveolar pain. Goals are to improve the understanding of the physiopathological mechanisms of persistent dentoalveolar pain and to highlight predictive criteria for the effectiveness of anesthetic blocks.
Read the detailed description
This is a proof of concept, randomized, controlled prospective pharmacological trial, single blind, with two parallel arms.
The main objective of the study is to evaluate the efficacy of repeated locoregional anesthetic blocks with bupivacaine in patient's persistent dentoalveolar pain compared to a control group receives a simulated anesthesia (local anesthesia with lidocaine).
The secondary objectives are :
- to evaluate the tolerance of repeated locoregional anesthetic blocks to bupivacaine patients with persistent dentoalveolar pain compared to control receiving simulated anesthesia (local anesthesia with lidocaine).
- to evaluate demographic and nosological predictive factors (age of symptoms, Quantitative Sensory Testing results) and psychometric (anxiety, depression, dramatization) of the effectiveness of anesthetic blocks.
After signing the informed consent, the patients participate will be randomized to anesthetic block treatment with bupivacaine or lidocaine.
During the 1st step of the study patients will participate at 6 visits (day -7, day 0, day 7, day 14, day 21 and M2) and will receive either a series of 4 locoregional anesthetic blocks with bupivacaine or a series of 4 local anesthesia with lidocaine ("simulated" control group) at day 0, day 7, day 14 and day 21. The main criterion is raised 2 months after the end of the series.
During the 2nd step
- The patients from experimental group will be followed until month 6 (2 visits: month 3 month 6).
- The patients from control group :
- will received in open (if they want) a series of 4 locoregional anesthetic blocks with bupivacaine (day56, day,63, day 70, day 77) and will be followed during 6 months after the first injection (7 visits: day 63, day 70, day 77, month 3, month 4, month 5, month 8)
- will be followed until month 6 ((2 visits: month 3 month 6).
- Conditions
- Pain
- Being tested
- Bupivacaine, Lidocaine
- Keywords
- Persistent dentoalveolar pain, bupivacaine, lidocaine, clinical trial, randomization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Injection of anesthetics blocks once a week during 4 weeks.
LidocaineDrug
Injection of anesthetics blocks once a week during 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | The dose received at each injection will be 5 mg. One injection per week will be carried out over 4 consecutive weeks Receives: Drug: Bupivacaine |
| Lidocaine | Sham comparator | The dose received at each injection will be 1.25mg. An injection unique per week will be carried out over 4 consecutive weeks. Receives: Drug: Bupivacaine; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients (with persistent dentoalveolar pain). with at least 30% pain reduction
Mean numerical scale on journal of pain (last 7 days)
Measured: difference compared to the basal value at day 0 (visit 1) to value at Month 2 (visit 6)
Secondary outcomes (3)
Brief Pain Inventory
This self-questionnaire will assess the pain intensity and impact of pain on the patient's life. He understands : a body image ; the maximum pain, the weakest pain, the usual pain of the last 15 days (numerical scale 0 to 10); the description of the current analgesic treatment; a assessment of relief by a percentage scale (0 to 100%); the study of the impact of pain on mood, relationships with other people, walking, sleep, work, joy of life, leisure, activities in general (scales numeric, rating from 0 (normal) to 10 (activity impossible).
Measured: The questionnaire will be completed at day-7, and month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.
Patient's Global Impression of Change (PGIC)
Its purpose is to evaluate in a general way the effectiveness of a treatment felt by the patient. This scale consists of 7 levels of descriptors answering the question "Since start of treatment, how would you describe the change (if any) in your limitations of activities, your symptoms, your emotions and your quality of life in general, related to your affection painful? ", Divided according to 3 modalities: improvement: (7) very, (6) medium, (5) slightly, unchanged( 4), worsen (3) slightly, (2) medium, (1) very.
Measured: The questionnaire will be completed at month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.
Neuropathic Pain Assessment Questionnaire (QEDN)
The Neuropathic Pain Assessment Questionnaire is a self-questionnaire that has been specifically validated to assess and monitor the different aspects of neuropathic pain and is sensitive to change. This questionnaire consists of twelve questions, ten of which relate to the description of pain by measuring its intensity using a numerical scale, that is, by grading the pain from 0 (no pain) to 10 (maximum pain imaginable). The remaining two questions each offer five answers about the duration of spontaneous pain over 24 hours (from "1 to 3 hours per day" to "continuously") and the number of painful seizures (paroxysms) over 24 hours (from "no painful crisis" to "more than 20"). The ten descriptive questions can be grouped into 5 dimensions. The sum of the 10 questions gives the total score scored on 100 and each dimension gives a sub-score.
Measured: The questionnaire will be completed at day-7, and month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start25 Aug 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- bupivacaine or lidocaine randomized treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Melin, BDS, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207411
- Sponsor's protocol ID
- RBHP 2018 MELIN (BADDAP)
- Other IDs
- 2018-002825-49, 2018
- Acronym
- BADDAP
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 31 Aug 2020
- 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repeated Locoregional Anesthetics Blocks With Bupivacaine in Patients Suffering of Chronic Dentoalveolar Pain. (BADDAP)
- ClinicalTrials.gov ID
- NCT04207411
- Acronym / sponsor ID
- BADDAP / RBHP 2018 MELIN (BADDAP)
- Conditions
- Pain
- Keywords
- Persistent dentoalveolar pain, bupivacaine, lidocaine, clinical trial, randomization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 20 Dec 2019 (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.
The aim of this study is to evaluate the efficacy of anesthetic blocks repeated with bupivacaine in the management of patients with persistent dentoalveolar pain. Goals are to improve the understanding of the physiopathological mechanisms of persistent dentoalveolar pain and to highlight predictive criteria for the effectiveness of anesthetic blocks.
Detailed description
This is a proof of concept, randomized, controlled prospective pharmacological trial, single blind, with two parallel arms.
The main objective of the study is to evaluate the efficacy of repeated locoregional anesthetic blocks with bupivacaine in patient's persistent dentoalveolar pain compared to a control group receives a simulated anesthesia (local anesthesia with lidocaine).
The secondary objectives are :
- to evaluate the tolerance of repeated locoregional anesthetic blocks to bupivacaine patients with persistent dentoalveolar pain compared to control receiving simulated anesthesia (local anesthesia with lidocaine).
- to evaluate demographic and nosological predictive factors (age of symptoms, Quantitative Sensory Testing results) and psychometric (anxiety, depression, dramatization) of the effectiveness of anesthetic blocks.
After signing the informed consent, the patients participate will be randomized to anesthetic block treatment with bupivacaine or lidocaine.
During the 1st step of the study patients will participate at 6 visits (day -7, day 0, day 7, day 14, day 21 and M2) and will receive either a series of 4 locoregional anesthetic blocks with bupivacaine or a series of 4 local anesthesia with lidocaine ("simulated" control group) at day 0, day 7, day 14 and day 21. The main criterion is raised 2 months after the end of the series.
During the 2nd step
- The patients from experimental group will be followed until month 6 (2 visits: month 3 month 6).
- The patients from control group :
- will received in open (if they want) a series of 4 locoregional anesthetic blocks with bupivacaine (day56, day,63, day 70, day 77) and will be followed during 6 months after the first injection (7 visits: day 63, day 70, day 77, month 3, month 4, month 5, month 8)
- will be followed until month 6 ((2 visits: month 3 month 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- bupivacaine or lidocaine randomized treatment.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: BupivacaineThe dose received at each injection will be 5 mg. One injection per week will be carried out over 4 consecutive weeks |
| Lidocaine | Sham comparator | Drug: Bupivacaine, Drug: LidocaineThe dose received at each injection will be 1.25mg. An injection unique per week will be carried out over 4 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient, male or female, over 18, with persistent dentoalveolar pain defined according to the criteria:
- Pain intensity greater than or equal to 4/10 on numerical scale
- Patient informed of the constraints of the study and having given his written consent. Benefiting of a social security scheme.
- Mastering correctly French.
Key exclusion criteria (11 listed)
- Pregnant women, breastfeeding, or likely to be pregnant.
- Oral pain of known origin (cancerous, infectious, traumatic).
- Patient having modified (stopped, started or modified dosage) in the last 2 month local or systemic medication that may interfere with the study results (for example, patients taking long-range psychotropic drugs will not be excluded).
- All medical pathology judged by the investigator as not compatible with the study.
- Known hypersensitivity to local amide-bound anesthetics or to any of the excipients
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 |
|---|---|---|
| BupivacaineInjection of anesthetics blocks once a week during 4 weeks. | Drug | Bupivacaine, Lidocaine |
| LidocaineInjection of anesthetics blocks once a week during 4 weeks. | Drug | Lidocaine |
Primary outcome
Proportion of patients (with persistent dentoalveolar pain). with at least 30% pain reduction
Time frame: difference compared to the basal value at day 0 (visit 1) to value at Month 2 (visit 6)
Mean numerical scale on journal of pain (last 7 days)
3 secondary outcomes
Brief Pain Inventory
Time frame: The questionnaire will be completed at day-7, and month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.
Patient's Global Impression of Change (PGIC)
Time frame: The questionnaire will be completed at month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.
Neuropathic Pain Assessment Questionnaire (QEDN)
Time frame: The questionnaire will be completed at day-7, and month 2 for all patients and then "month 3 and month 6" for patient of experimental group or visit month 4, month 5, month 8 for control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- 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.
Céline Melin, BDS, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine and Lidocaine in people with Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Aug 2020. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre, Pharm D (04 73 75 11 95 ext. 33, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients (with persistent dentoalveolar pain). with at least 30% pain reduction (time frame: difference compared to the basal value at day 0 (visit 1) to value at Month 2 (visit 6)). 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 31 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.