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

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 Overview

• Status: Completed
• Conditions: Intraoperative Hypertension
• Intervention / Treatment: Procedure: infraorbital block; Procedure: topical intranasal bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; the patients will receive bilateral infraorbital block	Procedure: infraorbital block; the patients will receive bilateral infraorbital block
Active Comparator: Group B; the patients will receive topical intranasal application of bupivacaine	Procedure: topical intranasal bupivacaine; the patients will receive topical intranasal application of bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2022
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: March 20, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pituitary Diseases; Adenoma; Pituitary Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MS-532-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No