Intraoperative HypertensionPhase 3NCT05301634
Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection
A Phase 3 study testing infraorbital block and topical intranasal bupivacaine in people with Intraoperative Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intraoperative Hypertension
- What is being tested?
- infraorbital block and topical intranasal bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2022to 15 Dec 2025
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I, II or III
- patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia
Who cannot join
- Patient's refusal
- Allergy to local anesthetics.
- Preoperative cerebrospinal fluid leak.
- Preoperative cardiac arrythmias.
- Seizure disorders.
- Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study
The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.
- Conditions
- Intraoperative Hypertension
- Being tested
- infraorbital block, topical intranasal bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infraorbital blockProcedure or surgery
the patients will receive bilateral infraorbital block
topical intranasal bupivacaineProcedure or surgery
the patients will receive topical intranasal application of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | the patients will receive bilateral infraorbital block Receives: Procedure: infraorbital block |
| Group B | Active comparator | the patients will receive topical intranasal application of bupivacaine Receives: Procedure: topical intranasal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure
Measured: at the time of mucosal dissection
Secondary outcomes (5)
Intraoperative need for magnesium sulphate
Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline
Measured: the entire duration of surgery
Intraoperative need for fentanyl
Intraoperative need for iv fentanyl blouses 0.5 μg/kg (maximum total dose 5 μg/kg for the entire procedure) if no response to magnesium sulphate
Measured: the entire duration of surgery
Intraoperative need for nitroglycerine
Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl
Measured: the entire duration of surgery
Postoperative need of pethidine
Postoperative need of pethidine boluses 25 mg with max.100 mg
Measured: 24 hours postoprative
Postoperative pain assessed by Numeric pain score
Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale [NRS] 0-100; 0 = Non ,100 = Worst imaginable pain)
Measured: 24 hours postoprative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 Apr 2022
- Primary completion30 Jul 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301634
- Sponsor's protocol ID
- MS-532-2021
- Status last verified
- May 2022
- First submitted
- 20 Mar 2022
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05301634
- Acronym / sponsor ID
- MS-532-2021
- Conditions
- Intraoperative Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 31 Mar 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.
The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: infraorbital blockthe patients will receive bilateral infraorbital block |
| Group B | Active comparator | Procedure: topical intranasal bupivacainethe patients will receive topical intranasal application of bupivacaine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I, II or III
- patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia
Key exclusion criteria (6 listed)
- Patient's refusal
- Allergy to local anesthetics.
- Preoperative cerebrospinal fluid leak.
- Preoperative cardiac arrythmias.
- Seizure disorders.
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 |
|---|---|---|
| infraorbital blockthe patients will receive bilateral infraorbital block | Procedure or surgery | Group A |
| topical intranasal bupivacainethe patients will receive topical intranasal application of bupivacaine | Procedure or surgery | Group B |
Primary outcome
Mean arterial blood pressure
Time frame: at the time of mucosal dissection
5 secondary outcomes
Intraoperative need for magnesium sulphate
Time frame: the entire duration of surgery
Intraoperative need for fentanyl
Time frame: the entire duration of surgery
Intraoperative need for nitroglycerine
Time frame: the entire duration of surgery
Postoperative need of pethidine
Time frame: 24 hours postoprative
Postoperative pain assessed by Numeric pain score
Time frame: 24 hours postoprative
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 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing infraorbital block and topical intranasal bupivacaine in people with Intraoperative Hypertension, run by Cairo 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 6 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 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean arterial blood pressure (time frame: at the time of mucosal dissection). 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 Dec 2025.