Anaesthesia
Conditions
Brief summary
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.
Interventions
PROCEDURESphenopalatine Ganglion Block trans oral approach saline injection
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.
PROCEDURESphenopalatine ganglion block trans oral approach bupivacaine injection
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 years - 80 years. 2. ASA I and ASA II patients. 3. Consented to participate in the research.
Exclusion criteria
1. Pregnant and breastfeeding females. 2. History of allergy to bupivacaine or other local anaesthetics. 3. Patients with uncontrolled hypertension, poorly controlled cardiovascular diseases, or cerebrovascular diseases. 4. Patients with pre-existing neurological conditions. 5. Patients with history of alcohol or drug abuse. 6. Patients on anticoagulation. 7. Occurrence of surgical or anaesthetic complications or change in the anaesthesia protocol. 8. Patients showing sensitivity to Bupivacaine. 9. Patients unable to understand VAS score. 10. Patients refusing to continue participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analogue Scale (VAS) pain score over the first 24 hours postoperatively. | in the PACU, at 2, 6, 12, and 24 hours after surgery | Postoperative pain will be assessed with a 10-cm scale visual analogue scale (VAS) (0 = no pain, 10 = worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total requirements of rescue analgesia | 24 hours postoperatively | Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesia |
| Time to first rescue analgesia | 24 hours postoperatively | 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 |
| Number of patients receiving rescue analgesia | 24 hours postoperatively | Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesic. |
| Incidence and severity of adverse effects and complications | 24 hours postoperatively | 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 |
Countries
Egypt
Outcome results
None listed