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

NCT06984913 | Completed

• 1 other identifier: 36264PR1183/4/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Surgical field condition

  The Fromme-Boezaart scale (6-point scale) will be used to assess the endoscopic surgical field condition after GA induction, at the entrance of the endoscope, and after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min. 0=No bleeding (cadaveric conditions). 1. Slight bleeding, no suctioning required. 2. Slight bleeding, occasional suctioning required. 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed. 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed. 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened, and surgery usually not possible.

  135 min post-procedure

Secondary Outcomes (8)

• Mean arterial pressure

  135 min post-procedure

• Heart rate

  135 min post-procedure

• Intraoperative fentanyl consumption

  Intraoperatively

• Intraoperative nitroglycerine consumption

  Intraoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (3)

Ultrasound group

EXPERIMENTAL

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

Other: Ultrasound-guided sphenopalatine ganglion block

Brainlab group

EXPERIMENTAL

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

Other: Brainlab navigation sphenopalatine ganglion block

Low dose Brainlab group

EXPERIMENTAL

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

Other: Low dose Brainlab navigation sphenopalatine ganglion block

Interventions

Ultrasound-guided sphenopalatine ganglion block OTHER

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

Ultrasound group

Brainlab navigation sphenopalatine ganglion block OTHER

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

Brainlab group

Low dose Brainlab navigation sphenopalatine ganglion block OTHER

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

Low dose Brainlab group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: May 22, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)