AnesthesiaNCT06174675
The Effect of Combined Bilateral Infraorbital and Infratrochlear Nerve Block in Nasal Surgeries
A study testing combined bilateral infraorbital and infratrochlear nerve blocks 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 a pre-emptive combined bilateral infraorbital and infratrochlear nerve blocks with bupivacaine 0.25% in decreasing intraoperative and postoperative analgesics consumption and maintaining intraoperative hemodynamic stability during nasal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- combined bilateral infraorbital and infratrochlear nerve blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: 18 - 55 years old.
- American Society of Anesthesiologists (ASA) Physical Status Class I or II
- Scheduled for elective nasal surgery under general anesthesia.
Who cannot join
- Refusing to participate in the study or inability to provide informed consent.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including coagulopathy, INR ≥ 1.4 and local infection).
- Compromised renal or liver functions.
- History of substance or alcohol abuse.
- Pre-existing chronic pain of different etiology.
- Psychiatric disorders.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Bilateral Infraorbital and Infratrochlear Nerve Block Versus Conventional Systemic Analgesia for Patients Undergoing Nasal Surgeries
The aim of the study is to assess the efficacy of adding a pre-emptive combined bilateral infraorbital and infratrochlear nerve blocks with bupivacaine 0.25% in decreasing intraoperative and postoperative analgesics consumption and maintaining intraoperative hemodynamic stability during nasal surgeries.
Read the detailed description
Perioperative pain management is one of the most important issues of most surgical procedures. The goal of every pain management technique is to reduce or eliminate pain and discomfort with minimum side effects (Garmella and Cellini, 2012).
Nasal surgical procedures are associated with a high incidence of emergence agitation leading to severe complications such as bleeding and delayed recovery which increase the hospital stay (Kim et al., 2015).
Although the cause of emergence agitation is not well established, Pain in the immediate post-operative period is one of the significant risk factors for emergence agitation. Multiple analgesic interventions are applied to the patient before, during and after surgery prevent these complications (Gray et al., 2018).
The most utilized analgesic interventions are combinations of narcotic and non-steroidal anti-inflammatory drugs. However, they are associated with gastrointestinal and neurological side effects which cause discomfort to the patient and affect surgical recovery profile (Çelik et al., 2018). Therefore, the utility of combining regional nerve block with general anesthesia has been popularized in clinical practice to provide improved perioperative analgesia, decreased narcotic consumption and enhanced emergence and recovery characteristics (Mariano et al., 2009; Ibrahim et al., 2018).
The infraorbital nerve (ION) is a branch of the maxillary part of the trigeminal nerve. This nerve innervates the skin of the nose and septum mobile nasi. The infratrochlear nerve (ITN) innervates the root of the nose and is an extraconal branch of the nasociliary nerve, which is a branch of the ophthalmic portion of the trigeminal nerve (Choi et al., 2019).
Although these nerve blocks are simple and easy to use with few complications, there are limited reports that suggest combined bilateral infraorbital and infratrochlear nerve blocks to be effective to facilitate pain management and reduce anesthetic agent consumption and perioperative dose of narcotics in nasal procedures (Cekic et al., 2013; Boselli et al., 2016).
- Conditions
- Anesthesia
- Being tested
- combined bilateral infraorbital and infratrochlear nerve blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined bilateral infraorbital and infratrochlear nerve blocksProcedure or surgery
Filling the block labelled syringe with 8 mL of bupivacaine 0.25%. Starting with Infraorbital nerve block using an extraoral approach.Inserting a 25-gauge needle laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. Positioning of the index finger of the non-dominant hand above the infraorbital foramen and advancing the needle feeling it beneath the finger to avoid globe penetration injury. Injecting 3 mL of the study solution slowly after confirming negative aspiration of blood and taking care not to inject into the foramen itself.
Shifting to infratrochlear nerve block by inserting the needle 1 cm above the inner canthus targeting the junction of the orbit and the nasal bone. Injecting 1mL of the study solution after confirming negative aspiration of blood.
Performing contralateral nerve block in the same manner. Applying pressure to four injection points for one minute to prevent hematoma.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | patients will receive combined bilateral infraorbital and infratrochlear nerve block.
20 patients Receives: Procedure: combined bilateral infraorbital and infratrochlear nerve blocks |
| control group | No intervention | patients will not receive the block and will receive intravenous analgesia according to standard protocol. 20 patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of intraoperative fentanyl
Measured: throughout the surgery
Secondary outcomes (6)
1. Hemodynamic changes
mean arterial blood pressure (MAP), heart rate (HR) will be recorded before anesthesia,
Measured: every 15 minutes during the surgery, upon arrival to the PACU and after 30 min.
The time from induction of anesthesia to the first additional dose of fentanyl intraoperative.
Measured: throughout the surgery
Total amount of postoperative pethidine given
Measured: 24 hours postoperatively
Number of patients needed rescue analgesia intraoperative or postoperative.
Measured: throughout the surgery and 24 hours postoperatively
Any complications related to the nerve block such as injection site pain, edema, hematoma or neurological deficits in the blocked area such as paresthesia or prolonged paralysis of the upper lip.
Measured: 24 hours postoperatively
Postoperative side effects such as nausea, vomiting and headache.
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 posted18 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Sep 2024
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Mohamed Elshaer, Ain Shams University
- Investigators
- Ayat Elshaer, ass.lecturer, Principal investigator, faculty of medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174675
- Sponsor's protocol ID
- FMASU MD136/2023
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2023
- Last updated
- 4 Dec 2024
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Bilateral Infraorbital and Infratrochlear Nerve Block Versus Conventional Systemic Analgesia for Patients Undergoing Nasal Surgeries
- ClinicalTrials.gov ID
- NCT06174675
- Acronym / sponsor ID
- FMASU MD136/2023
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 18 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 a pre-emptive combined bilateral infraorbital and infratrochlear nerve blocks with bupivacaine 0.25% in decreasing intraoperative and postoperative analgesics consumption and maintaining intraoperative hemodynamic stability during nasal surgeries.
Detailed description
Perioperative pain management is one of the most important issues of most surgical procedures. The goal of every pain management technique is to reduce or eliminate pain and discomfort with minimum side effects (Garmella and Cellini, 2012).
Nasal surgical procedures are associated with a high incidence of emergence agitation leading to severe complications such as bleeding and delayed recovery which increase the hospital stay (Kim et al., 2015).
Although the cause of emergence agitation is not well established, Pain in the immediate post-operative period is one of the significant risk factors for emergence agitation. Multiple analgesic interventions are applied to the patient before, during and after surgery prevent these complications (Gray et al., 2018).
The most utilized analgesic interventions are combinations of narcotic and non-steroidal anti-inflammatory drugs. However, they are associated with gastrointestinal and neurological side effects which cause discomfort to the patient and affect surgical recovery profile (Çelik et al., 2018). Therefore, the utility of combining regional nerve block with general anesthesia has been popularized in clinical practice to provide improved perioperative analgesia, decreased narcotic consumption and enhanced emergence and recovery characteristics (Mariano et al., 2009; Ibrahim et al., 2018).
The infraorbital nerve (ION) is a branch of the maxillary part of the trigeminal nerve. This nerve innervates the skin of the nose and septum mobile nasi. The infratrochlear nerve (ITN) innervates the root of the nose and is an extraconal branch of the nasociliary nerve, which is a branch of the ophthalmic portion of the trigeminal nerve (Choi et al., 2019).
Although these nerve blocks are simple and easy to use with few complications, there are limited reports that suggest combined bilateral infraorbital and infratrochlear nerve blocks to be effective to facilitate pain management and reduce anesthetic agent consumption and perioperative dose of narcotics in nasal procedures (Cekic et al., 2013; Boselli et al., 2016).
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 | Active comparator | Procedure: combined bilateral infraorbital and infratrochlear nerve blockspatients will receive combined bilateral infraorbital and infratrochlear nerve block. 20 patients |
| control group | No intervention | –patients will not receive the block and will receive intravenous analgesia according to standard protocol. 20 patients. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age group: 18 - 55 years old.
- American Society of Anesthesiologists (ASA) Physical Status Class I or II
- Scheduled for elective nasal surgery under general anesthesia.
Key exclusion criteria (8 listed)
- Refusing to participate in the study or inability to provide informed consent.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including coagulopathy, INR ≥ 1.4 and local infection).
- Compromised renal or liver functions.
- History of substance or alcohol abuse.
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 |
|---|---|---|
| combined bilateral infraorbital and infratrochlear nerve blocksFilling the block labelled syringe with 8 mL of bupivacaine 0.25%. Starting with Infraorbital nerve block using an extraoral approach.Inserting a 25-gauge needle laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. Positioning of the index finger of the non-dominant hand above the infraorbital foramen and advancing the needle feeling it beneath the finger to avoid globe penetration injury. Injecting 3 mL of the study solution slowly after confirming negative aspiration of blood and taking care not to inject into the foramen itself. Shifting to infratrochlear nerve block by inserting the needle 1 cm above the inner canthus targeting the junction of the orbit and the nasal bone. Injecting 1mL of the study solution after confirming negative aspiration of blood. Performing contralateral nerve block in the same manner. Applying pressure to four injection points for one minute to prevent hematoma. | Procedure or surgery | Study group |
Primary outcome
Total amount of intraoperative fentanyl
Time frame: throughout the surgery
6 secondary outcomes
1. Hemodynamic changes
Time frame: every 15 minutes during the surgery, upon arrival to the PACU and after 30 min.
The time from induction of anesthesia to the first additional dose of fentanyl intraoperative.
Time frame: throughout the surgery
Total amount of postoperative pethidine given
Time frame: 24 hours postoperatively
Number of patients needed rescue analgesia intraoperative or postoperative.
Time frame: throughout the surgery and 24 hours postoperatively
Any complications related to the nerve block such as injection site pain, edema, hematoma or neurological deficits in the blocked area such as paresthesia or prolonged paralysis of the upper lip.
Time frame: 24 hours postoperatively
Postoperative side effects such as nausea, vomiting and headache.
Time frame: 24 hours postoperatively
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 4 Dec 2024.
- 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.
Ayat Elshaer, 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 combined bilateral infraorbital and infratrochlear nerve blocks 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 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: finished, as of the sponsor's last update on 4 Dec 2024. 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 amount of intraoperative fentanyl (time frame: throughout 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 4 Dec 2024.