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

Not Applicable

Recruiting

• Conditions: Ultrasound; Brainlab Navigation; Sphenopalatine Ganglion Block; Functional Endoscopic Sinus Surgery

• Registration Number: NCT06984913
• Lead Sponsor: Tanta University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Study Start: 2025-05-22
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical field condition	135 min post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative nitroglycerine consumption	Intraoperatively	Intraoperative requirements of nitroglycerine will be calculated.
Incidence of adverse events	24 hours postoperatively	Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication
Mean arterial pressure	135 min post-procedure	Mean arterial pressure will be recorded after induction of general anesthesia, at entrance of endoscope, after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min.
Intraoperative fentanyl consumption	Intraoperatively	To improve the conditions of the surgical field, hemodynamics will be managed (A fixed target of mean blood pressure around 65 mmHg should be obtained) using these medications in the following order fentanyl 0.5 ug/kg.
Degree of pain	24 hours postoperatively	Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS: will be assessed at 0, 4, 8, 12, and 24 h postoperatively
Time to extubation	One hour postoperatively	Time to extubation: the time from discontinuing anesthesia to fulfilling extubation criteria will be recorded.
Recovery time	One hour postoperatively	Recovery time: the time from extubation, till patients attain an Aldrete score \>9, will be recorded.
Heart rate	135 min post-procedure	Heart rate will be recorded after induction of general anesthesia, at the entrance of the endoscope, after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt