Analgesianerve blockNCT05925465
Maxillary and Mandibular Nerve Block
A study testing Maxillary and mandibular nerve block in people with Analgesia, run by Mansoura University at 1 site in Egypt.
Trial summary
Mandibular fractures are among the most common (60-70%) maxillofacial fractures observed in emergency rooms. In the closed reduction (non-surgical), the bone fragments are realigned manually or by using traction devices. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Maxillary and mandibular nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I/II patients,
- within the age group of 21-60 years
- both sex
- scheduled for elective faciomaxillary surgery
Who cannot join
- Pregnant or breast-feeding women
- Patients with polytrauma
- Patients necessitating postoperative ventilation
- Oral or facial infection
- Coagulopathy
- Drug intake for chronic pain
- Known allergy to the study drugs
- Psychiatric disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Maha Ahmed AboZeid
Al Mansurah, Mansoura, 35511
Maha A AboZeid, mahazed@yahoo.com
Shimaa A Shalaby, MD
About this study
Official title: Effect of Combined Maxillary and Mandibular Nerve Block on Orthognathic Surgery Outcomes
Mandibular fractures are among the most common (60-70%) maxillofacial fractures observed in emergency rooms. In the closed reduction (non-surgical), the bone fragments are realigned manually or by using traction devices. The open reduction surgery of mandibular fractures should first ensure the restoration of the occlusion of the mandible to prevent postoperative malocclusion, followed by stabilization by means of rigid fixations such as plates, screws, and rigid intermaxillary blocks in order to minimise any nonunion, malunion, or delayed union of the fracture segments. These surgical procedures are associated with moderate postoperative pain, being the first 24 hours the most intense pain period. Maxillary and mandibular nerve blocks are performed in patients with refractory trigeminal neuralgia. However, there have been few studies evaluating the analgesic effects of these blocks for maxillofacial surgeries.
- Conditions
- Analgesia
- Being tested
- Maxillary and mandibular nerve block, Control
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary and mandibular nerve blockProcedure or surgery
receive bilateral combined maxillary and mandibular nerve block
ControlOther
not receive any nerve block
| Study group | Role | What they receive |
|---|---|---|
| Maxillary and mandibular nerve block (MMNB) group | Active comparator | receive bilateral combined maxillary and mandibular nerve block. Three mL of 0.5% isobaric bupivacaine will be injected for each nerve block after negative aspiration of blood. Receives: Procedure: Maxillary and mandibular nerve block |
| Control (C) group | Placebo comparator | not receive any nerve block Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative fentanyl rescue analgesic consumption
microgram
Measured: first 24 hours postoperatively
Secondary outcomes (7)
Intraoperative heart rate (HR)
beats per minute
Measured: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
Intraoperative mean arterial pressure (MAP)
mmHg
Measured: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
10-cm visual analogue scale (VAS)
where 0 represented no pain, and 10 meant the worst possible pain
Measured: at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively
Postoperative analgesic duration
hours
Measured: up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)
Patients' satisfaction about their analgesia
on a scale from 1 (poor), 2 (fair) to 3 (good)
Measured: 24 hours postoperatively
Total postoperative diclofenac sodium consumption
mg
Measured: 24 hours postoperatively
The total Intraoperative supplementary fentanyl
microgram
Measured: during the intraoperative duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Aug 2023
- Primary completion28 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into one of two groups, each of 30 patients, by means of coded envelopes to receive bilateral combined maxillary and mandibular nerve block (MNB group) or not receive any nerve block (control group)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925465
- Sponsor's protocol ID
- Jaw nerve block
- Acronym
- nerve block
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2023
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Maxillary and Mandibular Nerve Block on Orthognathic Surgery Outcomes
- ClinicalTrials.gov ID
- NCT05925465
- Acronym / sponsor ID
- nerve block / Jaw nerve block
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Jun 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.
Mandibular fractures are among the most common (60-70%) maxillofacial fractures observed in emergency rooms. In the closed reduction (non-surgical), the bone fragments are realigned manually or by using traction devices. The open reduction surgery of mandibular fractures should first ensure the restoration of the occlusion of the mandible to prevent postoperative malocclusion, followed by stabilization by means of rigid fixations such as plates, screws, and rigid intermaxillary blocks in order to minimise any nonunion, malunion, or delayed union of the fracture segments. These surgical procedures are associated with moderate postoperative pain, being the first 24 hours the most intense pain period. Maxillary and mandibular nerve blocks are performed in patients with refractory trigeminal neuralgia. However, there have been few studies evaluating the analgesic effects of these blocks for maxillofacial surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized into one of two groups, each of 30 patients, by means of coded envelopes to receive bilateral combined maxillary and mandibular nerve block (MNB group) or not receive any nerve block (control group)
| Arm | Type | Receives |
|---|---|---|
| Maxillary and mandibular nerve block (MMNB) group | Active comparator | Procedure: Maxillary and mandibular nerve blockreceive bilateral combined maxillary and mandibular nerve block. Three mL of 0.5% isobaric bupivacaine will be injected for each nerve block after negative aspiration of blood. |
| Control (C) group | Placebo comparator | Other: Controlnot receive any nerve block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) I/II patients,
- within the age group of 21-60 years
- both sex
- scheduled for elective faciomaxillary surgery
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women
- Patients with polytrauma
- Patients necessitating postoperative ventilation
- Oral or facial infection
- Coagulopathy
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 |
|---|---|---|
| Maxillary and mandibular nerve blockreceive bilateral combined maxillary and mandibular nerve block | Procedure or surgery | Maxillary and mandibular nerve block (MMNB) group |
| Controlnot receive any nerve block | Other | Control (C) group |
Primary outcome
Total postoperative fentanyl rescue analgesic consumption
Time frame: first 24 hours postoperatively
microgram
7 secondary outcomes
Intraoperative heart rate (HR)
Time frame: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
Intraoperative mean arterial pressure (MAP)
Time frame: each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively
10-cm visual analogue scale (VAS)
Time frame: at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively
Postoperative analgesic duration
Time frame: up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose)
Patients' satisfaction about their analgesia
Time frame: 24 hours postoperatively
Total postoperative diclofenac sodium consumption
Time frame: 24 hours postoperatively
The total Intraoperative supplementary fentanyl
Time frame: during the intraoperative duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary and mandibular nerve block in people with Analgesia, run by Mansoura 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha A AboZeid, MD (02-01019216192, mahazed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative fentanyl rescue analgesic consumption (time frame: first 24 hours postoperatively). 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 17 Feb 2026.