Brainlab Navigation, Functional Endoscopic Sinus Surgery, Sphenopalatine Ganglion Block, Ultrasound
Conditions
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.
Interventions
OTHERUltrasound-guided sphenopalatine ganglion block
Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%).
OTHERBrainlab navigation sphenopalatine ganglion block
Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%).
OTHERLow dose Brainlab navigation sphenopalatine ganglion block
Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Intraoperative nitroglycerine consumption | Intraoperatively | Intraoperative requirements of nitroglycerine will be calculated. |
| 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. |
| 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. |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication |
| 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 |
Countries
Egypt
Outcome results
None listed