Ultrasound-Guided Versus Brainlab Navigation Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery

NCT ID: NCT06984913

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2025-10-16

Brief Summary

This study compares ultrasound-guided and Brainlab navigation sphenopalatine ganglion block (SPGB) in functional endoscopic sinus surgery (FESS).

Detailed Description

Functional endoscopic sinus surgery (FESS) is the treatment modality of choice for the inflammatory disease of paranasal sinuses.

Sphenopalatine ganglion block (SPGB) is a regional analgesic technique that can be used as an alternative approach to reduce blood loss and improve the operative field during FESS without the need for hypotensive agents.

Ultrasound (US)-guided nerve block is a well-established technique in regional anesthesia and offers the advantage of real-time visualization of neural and vascular structures.

Conditions

Ultrasound; Brainlab Navigation; Sphenopalatine Ganglion Block; Functional Endoscopic Sinus Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound group

Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%).

Group Type: EXPERIMENTAL

Ultrasound-guided sphenopalatine ganglion block

Intervention Type: OTHER

Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%).

Brainlab group

Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%).

Group Type: EXPERIMENTAL

Brainlab navigation sphenopalatine ganglion block

Intervention Type: OTHER

Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%).

Low dose Brainlab group

Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose).

Group Type: EXPERIMENTAL

Low dose Brainlab navigation sphenopalatine ganglion block

Intervention Type: OTHER

Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose).

Interventions

Ultrasound-guided sphenopalatine ganglion block

Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%).

Intervention Type: OTHER

Brainlab navigation sphenopalatine ganglion block

Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%).

Intervention Type: OTHER

Low dose Brainlab navigation sphenopalatine ganglion block

Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Patients undergoing functional endoscopic sinus surgery under general anesthesia.

Exclusion Criteria

• Patients having a history of severe renal, hepatic, respiratory, cardiac disease, or a neurological condition.
• Drug or alcohol abuse.
• Chronic pain requires major analgesics, sedatives, or corticosteroids.
• Pregnant and lactating women.
• Hypersensitivity to local anesthetic agents.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Ismail Sharaf

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR1183/4/25

Identifier Type: -

Identifier Source: org_study_id