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

NCT ID: NCT05301634

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2025-12-15

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.

Detailed Description

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Conditions

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Intraoperative Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

the patients will receive bilateral infraorbital block

Group Type ACTIVE_COMPARATOR

infraorbital block

Intervention Type PROCEDURE

the patients will receive bilateral infraorbital block

Group B

the patients will receive topical intranasal application of bupivacaine

Group Type ACTIVE_COMPARATOR

topical intranasal bupivacaine

Intervention Type PROCEDURE

the patients will receive topical intranasal application of bupivacaine

Interventions

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infraorbital block

the patients will receive bilateral infraorbital block

Intervention Type PROCEDURE

topical intranasal bupivacaine

the patients will receive topical intranasal application of bupivacaine

Intervention Type PROCEDURE

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Alaini hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-532-2021

Identifier Type: -

Identifier Source: org_study_id