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NCT Number: NCT06984913

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

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

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Key information

Conditions

Ultrasound Brainlab Navigation Functional Endoscopic Sinus Surgery Sphenopalatine Ganglion Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided sphenopalatine ganglion block

Other

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

Brainlab navigation sphenopalatine ganglion block

Other

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

Low dose Brainlab navigation sphenopalatine ganglion block

Other

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

Primary outcomes

  1. Surgical field condition

    Time frame: 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).

    • Slight bleeding, no suctioning required.
    • Slight bleeding, occasional suctioning required.
    • Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed.
    • Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed.
    • Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened, and surgery usually not possible.

Secondary outcomes

  1. Mean arterial pressure

    Time frame: 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.

  2. Heart rate

    Time frame: 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.

  3. Intraoperative fentanyl consumption

    Time frame: 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.

  4. Intraoperative nitroglycerine consumption

    Time frame: Intraoperatively

    Intraoperative requirements of nitroglycerine will be calculated.

  5. Degree of pain

    Time frame: 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

  6. Time to extubation

    Time frame: One hour postoperatively

    Time to extubation: the time from discontinuing anesthesia to fulfilling extubation criteria will be recorded.

  7. Recovery time

    Time frame: One hour postoperatively

    Recovery time: the time from extubation, till patients attain an Aldrete score >9, will be recorded.

  8. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Ultrasound-Guided Versus Brainlab Navigation Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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