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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intraoperative Hypertension

Intervention / Treatment
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* Procedure: infraorbital block
* Procedure: topical intranasal bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>the patients will receive bilateral infraorbital block | Procedure: infraorbital block<br>* the patients will receive bilateral infraorbital block<br>|
| Active Comparator: Group B<br>the patients will receive topical intranasal application of bupivacaine | Procedure: topical intranasal bupivacaine<br>* the patients will receive topical intranasal application of bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure |  | at the time of mucosal dissection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative need for magnesium sulphate | Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline | 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 | 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 | the entire duration of surgery | 
| Postoperative need of pethidine | Postoperative need of pethidine boluses 25 mg with max.100 mg | 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) | 24 hours postoprative |