Maxillofacial InjuriesNCT05567497
Ultrasound Guided Trigeminal Nerve Block in Maxillofacial Surgeries
A study testing trigeminal nerve block in people with Maxillofacial Injuries, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study aims to evaluate the perioperative analgesic effect of USG Trigeminal Nerve Block in adult patients undergoing maxillofacial surgery. We hypothesized that giving USG-guided TNB in patients undergoing maxilla-facial surgery could reduce the requirements of opioids perioperatively and avoid the side effects… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Maxillofacial Injuries
- What is being tested?
- trigeminal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Mar 2023
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American society of anesthesia (ASA) criteria I/II
- Scheduled for elective unilateral maxillo-facial surgery
Who cannot join
- Patients with polytrauma and fracture base of skull.
- Patients with known allergy to the study drugs.
- Patients with coagulopathy.
- Patients with infection at puncture site.
- Patients necessitating postoperative ventilation from the start, since it will be difficult to assess respiratory depression and postoperative pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Perioperative Analgesic Effect of Ultrasound-guided Trigeminal Nerve Block in Adult Patients Undergoing Maxillo-facial Surgery Under General Anesthesia: A Randomized Controlled Study
This study aims to evaluate the perioperative analgesic effect of USG Trigeminal Nerve Block in adult patients undergoing maxillofacial surgery. We hypothesized that giving USG-guided TNB in patients undergoing maxilla-facial surgery could reduce the requirements of opioids perioperatively and avoid the side effects of opioids used.
The aim of this double-blind study is to evaluate the effect of USG-guided TNB intra- and post-operatively in terms of pain relief, opioid consumption and adverse effects in patients undergoing such elective surgeries.
Read the detailed description
Nerve block using various agents has been proposed as a part of the multimodal analgesia to decrease consumption of intravenous opioids and also decrease its complications such as respiratory depression. Recent research has focused on the role of trigeminal nerve blocks (TNB) for management of facial pain . This block was found to be effective in trigeminalneuralgia , palate surgeries and oral and dental surgeries.
Anatomically, the Gasserian ganglion lies in the middle cranial fossa within the Meckel's cave and gives rise to three branches (1) ophthalmic, (2) maxillary, and (3) mandibular which exit from skull through three distinct foramina: the superior orbital fissure, the foramen rotundum, and the foramen ovale. The injection anterior and medial to lateral pterygoid plate into the upper part of pterygopalatine fossa (PPF) will place the injectate in close vicinity to foramen rotundum from where drug migrates into the middle cranial fossa. Since the PPF is extremely vascular, visualizing vascular and soft tissue structures in real time minimize the potential inadvertent complications.
Fluoroscopy-guided blocks have long been considered the gold standard practice in head and neck pain management. Alternatively, computed tomography-guided procedures provide a useful option but expensive and have radiation hazard. Lately, ultrasonography (USG) has been used extensively for perioperative pain relief providing excellent visualization of soft tissue and vasculature with real-time needle placement.
To date, very few published studies had evaluated the value of USG-guided TNB for control of perioperative pain in maxillofacial surgery.
- Conditions
- Maxillofacial Injuries
- Being tested
- trigeminal nerve block
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trigeminal nerve blockProcedure or surgery
ultrasound guided trigeminal nerve block
| Study group | Role | What they receive |
|---|---|---|
| Trigeminal Nerve Block (TNB) | Active comparator | patients will receive general anesthesia followed 5 ml of 0.25% Bupivacaine for TGB under USG after induction of anesthesia (Block Group). Receives: Procedure: trigeminal nerve block |
| control | No intervention | patients will receive general anesthesia only (Control Group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
total fentanyl consumption during the intraoperative period.
the amount of the fentanyl that will be used intraoperatively as analgesia
Measured: immediately at the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Nov 2022
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
- Investigators
- Abdelrhman Alshawadfy, MD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567497
- Sponsor's protocol ID
- Trigeminal nerve block
- Status last verified
- Dec 2022
- First submitted
- 25 Sep 2022
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Perioperative Analgesic Effect of Ultrasound-guided Trigeminal Nerve Block in Adult Patients Undergoing Maxillo-facial Surgery Under General Anesthesia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05567497
- Acronym / sponsor ID
- Trigeminal nerve block
- Conditions
- Maxillofacial Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 5 Oct 2022 (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.
This study aims to evaluate the perioperative analgesic effect of USG Trigeminal Nerve Block in adult patients undergoing maxillofacial surgery. We hypothesized that giving USG-guided TNB in patients undergoing maxilla-facial surgery could reduce the requirements of opioids perioperatively and avoid the side effects of opioids used.
The aim of this double-blind study is to evaluate the effect of USG-guided TNB intra- and post-operatively in terms of pain relief, opioid consumption and adverse effects in patients undergoing such elective surgeries.
Detailed description
Nerve block using various agents has been proposed as a part of the multimodal analgesia to decrease consumption of intravenous opioids and also decrease its complications such as respiratory depression. Recent research has focused on the role of trigeminal nerve blocks (TNB) for management of facial pain . This block was found to be effective in trigeminalneuralgia , palate surgeries and oral and dental surgeries.
Anatomically, the Gasserian ganglion lies in the middle cranial fossa within the Meckel's cave and gives rise to three branches (1) ophthalmic, (2) maxillary, and (3) mandibular which exit from skull through three distinct foramina: the superior orbital fissure, the foramen rotundum, and the foramen ovale. The injection anterior and medial to lateral pterygoid plate into the upper part of pterygopalatine fossa (PPF) will place the injectate in close vicinity to foramen rotundum from where drug migrates into the middle cranial fossa. Since the PPF is extremely vascular, visualizing vascular and soft tissue structures in real time minimize the potential inadvertent complications.
Fluoroscopy-guided blocks have long been considered the gold standard practice in head and neck pain management. Alternatively, computed tomography-guided procedures provide a useful option but expensive and have radiation hazard. Lately, ultrasonography (USG) has been used extensively for perioperative pain relief providing excellent visualization of soft tissue and vasculature with real-time needle placement.
To date, very few published studies had evaluated the value of USG-guided TNB for control of perioperative pain in maxillofacial surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trigeminal Nerve Block (TNB) | Active comparator | Procedure: trigeminal nerve blockpatients will receive general anesthesia followed 5 ml of 0.25% Bupivacaine for TGB under USG after induction of anesthesia (Block Group). |
| control | No intervention | –patients will receive general anesthesia only (Control Group). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American society of anesthesia (ASA) criteria I/II
- Scheduled for elective unilateral maxillo-facial surgery
Key exclusion criteria (5 listed)
- Patients with polytrauma and fracture base of skull.
- Patients with known allergy to the study drugs.
- Patients with coagulopathy.
- Patients with infection at puncture site.
- Patients necessitating postoperative ventilation from the start, since it will be difficult to assess respiratory depression and postoperative pain.
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 |
|---|---|---|
| trigeminal nerve blockultrasound guided trigeminal nerve block | Procedure or surgery | Trigeminal Nerve Block (TNB) |
Primary outcome
total fentanyl consumption during the intraoperative period.
Time frame: immediately at the end of the surgery
the amount of the fentanyl that will be used intraoperatively as analgesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- 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.
Abdelrhman Alshawadfy, MD principal investigator
Suez Canal 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 trigeminal nerve block in people with Maxillofacial Injuries, run by Suez Canal 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 2 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: finished, as of the sponsor's last update on 30 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
total fentanyl consumption during the intraoperative period. (time frame: immediately at the end of the surgery). 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 30 Apr 2025.