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

Intraoperative Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301634
• Other study ID #: MS-532-2021
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2, 2022
• Est. completion date: October 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Intraoperative Hypertension
• Pituitary Neoplasms

Intervention

Procedure:
• infraorbital block
the patients will receive bilateral infraorbital block
• topical intranasal bupivacaine
the patients will receive topical intranasal application of bupivacaine

Locations

Country	Name	City	State
Egypt	Kasr Alaini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial blood pressure		at the time of mucosal dissection
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative need of pethidine	Postoperative need of pethidine boluses 25 mg with max.100 mg	24 hours postoprative
Secondary	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