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Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure that is used in many inflammatory and infectious sinus diseases. Acute postoperative pain can lead to adverse consequences and good postoperative treatment of pain is essential. There is no agreement on a single protocol to treat pain after endoscopic sinus surgeries, and the usually used analgesics have some side effects that hinder their use. Current evidence is insufficient for routine clinical use of the sphenopalatine ganglion block for Functional endoscopic sinus surgery and the efficacy of sphenopalatine ganglion block for pain control after functional endoscopic sinus surgery remains controversial. This study aims to explore the influence of sphenopalatine ganglion block on pain intensity after functional endoscopic sinus surgery by comparing two groups, a group receiving the block with Bupivacaine injection, versus saline injection in the other group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (control group) (n= 35 ) | Active Comparator | 1.5 ml of normal saline was injected in the greater palatine foramen |
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| Group B (Bupivacaine group) (n= 35) | Active Comparator | 1.5 ml of Bupivacaine was injected in the greater palatine foramen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphenopalatine Ganglion Block trans oral approach saline injection | Procedure | The sphenopalatine block will be done by the end of the operation using a trans-oral approach at the greater palatine foramen with the help of a Macintosh blade number 3 for good visualization of the hard and soft palate using a 25 Gauge 1.5 inch needle curved at 45 degrees 25 mm from the tip and filled with 1.5 ml of normal saline. The greater palatine foramen is located posteromedial to the third maxillary molar and anteromedial to the pterygoid hamulus and maxillary tuberosity. The foramen will be identified by digital palpation, and the needle will be inserted until reaching the bone then redirected slightly until the foramen is localized and the needle easily gets in the greater palatine canal. aspiration will be done to ensure that no blood vessels are punctured, and the solution will be injected. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analogue Scale (VAS) pain score over the first 24 hours postoperatively. | Postoperative pain will be assessed with a 10-cm scale visual analogue scale (VAS) (0 = no pain, 10 = worst imaginable pain) | in the PACU, at 2, 6, 12, and 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue analgesia | Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesic and the time to the first rescue analgesia will be recorded | 24 hours postoperatively |
| Total requirements of rescue analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| Sphenopalatine ganglion block trans oral approach bupivacaine injection | Procedure | The sphenopalatine block will be done by the end of the operation using a trans-oral approach at the greater palatine foramen with the help of a Macintosh blade number 3 for good visualization of the hard and soft palate using a 25 Gauge 1.5 inch needle curved at 45 degrees 25 mm from the tip and filled with 1.5 ml of bupivacaine. The greater palatine foramen is located posteromedial to the third maxillary molar and anteromedial to the pterygoid hamulus and maxillary tuberosity. The foramen will be identified by digital palpation, and the needle will be inserted until reaching the bone then redirected slightly until the foramen is localized and the needle easily gets in the greater palatine canal. aspiration will be done to ensure that no blood vessels are punctured, and the solution will be injected. |
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Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesia |
| 24 hours postoperatively |
| Number of patients receiving rescue analgesia | Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesic. | 24 hours postoperatively |
| Incidence and severity of adverse effects and complications | Incidence and severity of adverse effects and complications such as nausea and vomiting (PONV), headache, visual disturbances, sore throat and swallowing difficulty during the first 24 hours postoperatively | 24 hours postoperatively |