Sphenopalatine Ganglion Block with Bupivacaine and Its Effect on Pain After Functional Endoscopic Sinus Surgery

Not Applicable

Completed

• Conditions: Anaesthesia

• Registration Number: NCT06847425
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-01
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt