Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05301634

Enrollment

Registered

2022-03-31

Start date

2022-04-02

Completion date

2025-12-15

Last updated

2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypertension

Brief 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 analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.

Interventions

PROCEDUREinfraorbital block

the patients will receive bilateral infraorbital block

PROCEDUREtopical intranasal bupivacaine

the patients will receive topical intranasal application of bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* ASA I, II or III * patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Mean arterial blood pressure	at the time of mucosal dissection

Secondary

Measure	Time frame	Description
Intraoperative need for magnesium sulphate	the entire duration of surgery	Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline
Intraoperative need for fentanyl	the entire duration of surgery	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
Intraoperative need for nitroglycerine	the entire duration of surgery	Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl
Postoperative need of pethidine	24 hours postoprative	Postoperative need of pethidine boluses 25 mg with max.100 mg
Postoperative pain assessed by Numeric pain score	24 hours postoprative	Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale \[NRS\] 0-100; 0 = Non ,100 = Worst imaginable pain)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026