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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Intraoperative Hypertension

Treatments: Procedure: topical intranasal bupivacaine; Procedure: infraorbital block

Study type: Interventional

Funder types: Other

Identifiers

NCT05301634

MS-532-2021

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group A

Active Comparator group

Description:

the patients will receive bilateral infraorbital block

Treatment:

Procedure: infraorbital block

Group B

Active Comparator group

Description:

the patients will receive topical intranasal application of bupivacaine

Treatment:

Procedure: topical intranasal bupivacaine