Postoperative PainPhase 4NCT06243263
Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery
A Phase 4 study testing Bupivacain in people with Postoperative Pain and Mandible Fracture, run by University Tunis El Manar at 2 sites in Tunisia.
Trial summary
Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Mandible Fracture, Analgesia
- What is being tested?
- Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTunisia
- Study dates
- 6 Feb 2024to 4 Mar 2024
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
- Proposed for open reduction and internal fixation of their fractures under general anesthesia;
- Having provided their informed and documented consent on a consent form.
Who cannot join
- Pathological mandibular fractures;
- History of mandibular fractures;
- Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
- Patients suffering from trigeminal neuralgia;
- Dental care performed in the month preceding the trauma;
- Patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures;
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- Patients on anticoagulants;
- Porphyrias;
- History of malignant hyperthermia;
- Known allergy to local anesthetics;
- Pregnancy or breastfeeding;
- Severe heart failure;
- Atrioventricular conduction disorders;
- Uncontrolled epilepsy;
- Hemostatic disorders;
- Non-cooperative patients.
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites, 1 recruiting
- Recruiting
Charles Nicole Hospital
Tunis, 1002
ISSAM M ZAIRI, PhD
- Completed
Charles Nicolle Hospital of Tunis
Tunis, 1053
About this study
Official title: Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial
Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.
The main question it aims to answer are:
Read more
- Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
- Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?
Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.
The patient:
- Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
- They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.
Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.
- Conditions
- Postoperative Pain, Mandible Fracture, Analgesia, Anesthesia, Local
- Being tested
- Bupivacain
- Keywords
- Mandibular Fracture, Postoperative pain, Inferior alveolar nerve block, Analgesia
- Medical subject headings
- Pain, Postoperative, Mandibular Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
At the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized.
| Study group | Role | What they receive |
|---|---|---|
| Group BNAI+ | Experimental | Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will receive an inferior alveolar nerve block with bupivacaine.
All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours. Receives: Drug: Bupivacain |
| Group BNAI- | No intervention | Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will not receive an inferior alveolar nerve block with bupivacaine ( control group). All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
questionnaire with a numerical scale (0 - 10)
Measured: 8 hours post-operatively
Secondary outcomes (3)
Post-operative pain
questionnaire with a numerical scale (0 - 10)
Measured: 2, 4 , 12, 24 hours post-operatively
Adverse effects
questionnaire including the presence or absence of any abnormal sensations, change in taste, nausea, constipation, fever, diaphoresis, vomiting, light-headedness, palpitations, or headache. The notice of an hematoma or in infection at the site of the injection
Measured: 24 hours post-operatively
The number of instances of rescue analgesia
We will record the number of instances of rescue analgesia following the description of intense pain for each hemi-mandible group.
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start6 Feb 2024 (estimated)
- Primary completion4 Mar 2024 (estimated)
- Study completion4 Mar 2024 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block with bupivacaine.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Sanaa, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243263
- Sponsor's protocol ID
- T00000228
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery: a Double Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06243263
- Acronym / sponsor ID
- T00000228
- Conditions
- Postoperative Pain, Mandible Fracture, Analgesia, Anesthesia, Local
- Keywords
- Mandibular Fracture, Postoperative pain, Inferior alveolar nerve block, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 6 Feb 2024 (estimated)
- Primary completion
- 4 Mar 2024 (estimated)
- Study completion
- 4 Mar 2024 (estimated)
- First posted
- 6 Feb 2024 (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.
Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.
The main question it aims to answer are:
- Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
- Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?
Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.
The patient:
- Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
- They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.
Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block with bupivacaine.
| Arm | Type | Receives |
|---|---|---|
| Group BNAI+ | Experimental | Drug: BupivacainRandomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will receive an inferior alveolar nerve block with bupivacaine. All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours. |
| Group BNAI- | No intervention | –Randomization process will be used to preoperatively assign patient's left or right side to receive inferior alveolar nerve block. At the end of the surgery, each patient will receive an inferior alveolar nerve block with 2ml of bupivacaine 0.5% on one side ;the other side will not be injected. This arm include the group of fracture which will not receive an inferior alveolar nerve block with bupivacaine ( control group). All patient will receive during the postoperative period 1 gram of paracetamol each 8 hours. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
- Proposed for open reduction and internal fixation of their fractures under general anesthesia;
- Having provided their informed and documented consent on a consent form.
Key exclusion criteria (16 listed)
- Pathological mandibular fractures;
- History of mandibular fractures;
- Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
- Patients suffering from trigeminal neuralgia;
- Dental care performed in the month preceding the trauma;
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 |
|---|---|---|
| BupivacainAt the end of the surgery, after wound closure, an inferior alveolar nerve block with 2ml bupivacaine 0,5 % will be realized. | Drug | Group BNAI+ |
Primary outcome
Post-operative pain
Time frame: 8 hours post-operatively
questionnaire with a numerical scale (0 - 10)
3 secondary outcomes
Post-operative pain
Time frame: 2, 4 , 12, 24 hours post-operatively
Adverse effects
Time frame: 24 hours post-operatively
The number of instances of rescue analgesia
Time frame: 24 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain in people with Postoperative Pain and Mandible Fracture, run by University Tunis El Manar at 2 sites in Tunisia.
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 3 inclusion and 16 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 yasmine sanaa, MD (+21658330834, yasmine.sanaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 8 hours post-operatively). 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 14 Feb 2024.