AnesthesiaNCT06167187
The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries
A study testing bilateral inferior alveolar nerve block and Ketorolac and fentanyl in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- bilateral inferior alveolar nerve block and Ketorolac and fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to Jun 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group: 18 - 65 years old.
- American Society of Anesthesiologists (ASA) Physical Status Class I to III
- Scheduled for fracture mandible fixation.
Who cannot join
- Refusing to participate in the study.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including coagulopathy and local infection).
- Psychiatric disorders.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine - Ain shams university hospitals
Cairo, 11591
Mohamed Atef, Ass.lecturer, +201065270020, Moahmed.Atef@med.asu.edu.eg
About this study
Official title: Is Inferior Alveolar Nerve Block Beneficial in Fracture Mandibular Surgeries? A Randomised Controlled Trial
The aim of the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries.
Read the detailed description
Opioid drug administration is a common technique to reduce pain from surgical trauma. However, the use of large doses of opioid drugs during and after surgery can be associated with an increased incidence of multiple side effects such as; ventilatory depression, sedation, nausea, vomiting, pruritus, difficult voiding and ileus.
In maxillofacial surgeries in which patients often receive maxillomandibular fixation these side effects are troublesome to the patient and at worst case scenario can cause a life-threatening complications. Ventilatory depression and vomiting are the most serious side effects especially in early postoperative hours. Various methods have been proposed to minimize these side effects. Nerve block with long-acting local anesthesia is a proposed technique in this regard.
In maxillofacial operations, bupivacaine is a highly efficient long-acting local anesthetic and has been used as a safe local anesthetic for neuroanalgesia after cleft lip operation or third molar surgery alone or in combination with low-power laser and diclofenac.
Inferior alveolar nerve block is considered as gold standard for sensory block of the hemi mandible. It can provide adequate anesthesia and analgesia for one side of the mandibular teeth and gingival mucosa, the body and inferior ramus of the mandible, the anterior two-thirds of the tongue and floor of the mouth cavity.
The inferior alveolar nerve (IAN) block is a widely used regional anaesthetic nerve block for the mandible. The most commonly used technique for IAN block is called the direct approach which include inserting the needle into the pterygomandibular raphae by penetrating the buccinators muscle. Once in this space, the aim is to inject the local anaesthetic solution besides the inferior alveolar nerve before it enters the mandibular foramen.
- Conditions
- Anesthesia
- Being tested
- bilateral inferior alveolar nerve block, Ketorolac and fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral inferior alveolar nerve blockProcedure or surgery
Also called IANB
Placing the tip of the thumb or forefinger into the coronoid notch (retromolar fossa) to help visualize the vertical height at which the needle will enter, and retracting the cheek to expose the pterygomandibular triangle. Placing the barrel of the syringe over the contralateral lower 1st and 2nd premolars and resting the side of the needle tip against the lateral edge of the pterygomandibular raphe, aiming the tip of the needle into the pterygomandibular triangle, with the bevel facing the ramus. Advancing the needle tip slightly into the mucosa until it is stopped by the ramus (typically after about 2 to 2.5 cm of insertion) and withdrawing needle 1 mm away from bone. Aspirating to rule out intravascular placement. If aspiration reveals intravascular placement, withdrawal of the needle will be done 2 to 3 mm, then reaspirating prior to injection. Slowly injecting about 2 to 4 milliliters of bupivacaine 0.5% anesthetic in each side..
Ketorolac and fentanylDrug
in control group, Patients will not receive the block and pain will be controlled according to institutional protocol using 30 mg ketorolac IV and fentanyl increments as needed.
| Study group | Role | What they receive |
|---|---|---|
| Study group (IAN block group) | Active comparator | patients will receive bilateral inferior alveolar nerve block. 23 patients Receives: Procedure: bilateral inferior alveolar nerve block |
| control group | Active comparator | patients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol.
23 patients Receives: Drug: Ketorolac and fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of the first dose of fentanyl rescue analgesia intraoperative
guided by hemodynamic changes
Measured: Throughout the surgery
Total amount of additional intraoperative fentanyl rescue analgesia
guided by hemodynamic changes
Measured: Throughout the surgery
The time from recovery to the first dose pethidine rescue analgesic
guided by visual analogue scale.
Measured: 24 hours postoperatively
Total amount of pethidine postoperative rescue analgesic
guided by visual analogue scale.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Incidence of complications related to the block
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jun 2023
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed atef, Ain Shams University
- Investigators
- Mohamed Atef, ass.lecturer, Principal investigator, faculty of medicine, ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167187
- Sponsor's protocol ID
- FMASU MD94/2023
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Inferior Alveolar Nerve Block Beneficial in Fracture Mandibular Surgeries? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06167187
- Acronym / sponsor ID
- FMASU MD94/2023
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Dec 2023 (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 the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries.
Detailed description
Opioid drug administration is a common technique to reduce pain from surgical trauma. However, the use of large doses of opioid drugs during and after surgery can be associated with an increased incidence of multiple side effects such as; ventilatory depression, sedation, nausea, vomiting, pruritus, difficult voiding and ileus.
In maxillofacial surgeries in which patients often receive maxillomandibular fixation these side effects are troublesome to the patient and at worst case scenario can cause a life-threatening complications. Ventilatory depression and vomiting are the most serious side effects especially in early postoperative hours. Various methods have been proposed to minimize these side effects. Nerve block with long-acting local anesthesia is a proposed technique in this regard.
In maxillofacial operations, bupivacaine is a highly efficient long-acting local anesthetic and has been used as a safe local anesthetic for neuroanalgesia after cleft lip operation or third molar surgery alone or in combination with low-power laser and diclofenac.
Inferior alveolar nerve block is considered as gold standard for sensory block of the hemi mandible. It can provide adequate anesthesia and analgesia for one side of the mandibular teeth and gingival mucosa, the body and inferior ramus of the mandible, the anterior two-thirds of the tongue and floor of the mouth cavity.
The inferior alveolar nerve (IAN) block is a widely used regional anaesthetic nerve block for the mandible. The most commonly used technique for IAN block is called the direct approach which include inserting the needle into the pterygomandibular raphae by penetrating the buccinators muscle. Once in this space, the aim is to inject the local anaesthetic solution besides the inferior alveolar nerve before it enters the mandibular foramen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (IAN block group) | Active comparator | Procedure: bilateral inferior alveolar nerve blockpatients will receive bilateral inferior alveolar nerve block. 23 patients |
| control group | Active comparator | Drug: Ketorolac and fentanylpatients will not receive the block and will receive intravenous multimodal analgesia according to standard protocol. 23 patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age group: 18 - 65 years old.
- American Society of Anesthesiologists (ASA) Physical Status Class I to III
- Scheduled for fracture mandible fixation.
Key exclusion criteria (5 listed)
- Refusing to participate in the study.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including coagulopathy and local infection).
- Psychiatric disorders.
- Pregnancy.
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 |
|---|---|---|
| bilateral inferior alveolar nerve blockAlso: IANBPlacing the tip of the thumb or forefinger into the coronoid notch (retromolar fossa) to help visualize the vertical height at which the needle will enter, and retracting the cheek to expose the pterygomandibular triangle. Placing the barrel of the syringe over the contralateral lower 1st and 2nd premolars and resting the side of the needle tip against the lateral edge of the pterygomandibular raphe, aiming the tip of the needle into the pterygomandibular triangle, with the bevel facing the ramus. Advancing the needle tip slightly into the mucosa until it is stopped by the ramus (typically after about 2 to 2.5 cm of insertion) and withdrawing needle 1 mm away from bone. Aspirating to rule out intravascular placement. If aspiration reveals intravascular placement, withdrawal of the needle will be done 2 to 3 mm, then reaspirating prior to injection. Slowly injecting about 2 to 4 milliliters of bupivacaine 0.5% anesthetic in each side.. | Procedure or surgery | Study group (IAN block group) |
| Ketorolac and fentanylin control group, Patients will not receive the block and pain will be controlled according to institutional protocol using 30 mg ketorolac IV and fentanyl increments as needed. | Drug | control group |
Primary outcome
The time of the first dose of fentanyl rescue analgesia intraoperative
Time frame: Throughout the surgery
guided by hemodynamic changes
Total amount of additional intraoperative fentanyl rescue analgesia
Time frame: Throughout the surgery
guided by hemodynamic changes
The time from recovery to the first dose pethidine rescue analgesic
Time frame: 24 hours postoperatively
guided by visual analogue scale.
Total amount of pethidine postoperative rescue analgesic
Time frame: 24 hours postoperatively
guided by visual analogue scale.
1 secondary outcome
Incidence of complications related to the block
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
Mohamed Atef, ass.lecturer principal investigator
faculty of medicine, ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral inferior alveolar nerve block and Ketorolac and fentanyl in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Atef, ass.lecturer (00201065270020, Moahmed.Atef@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of the first dose of fentanyl rescue analgesia intraoperative (time frame: Throughout the surgery). The study lists 4 primary outcomes in all. 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 12 Dec 2023.