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

Phase 3

• Conditions: Intraoperative Hypertension
• Interventions: Procedure: infraorbital block; Procedure: topical intranasal bupivacaine

• Registration Number: NCT05301634
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-20
• Study First Posted: 2022-03-31
• Study Start: 2022-04-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24
• Primary Completion: 2022-09
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	infraorbital block	the patients will receive bilateral infraorbital block
Group B	topical intranasal bupivacaine	the patients will receive topical intranasal application of bupivacaine

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	at the time of mucosal dissection

Secondary Outcome Measures

Name	Time	Method
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
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
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)

Trial Locations

Locations (1)

Kasr Alaini hospital; 🇪🇬 Cairo, Egypt