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

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.

Study Overview

• Status: Completed
• Conditions: Anaesthesia
• Intervention / Treatment: Procedure: Sphenopalatine Ganglion Block trans oral approach saline injection; Procedure: Sphenopalatine ganglion block trans oral approach bupivacaine injection

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (control group) (n= 35 ); 1.5 ml of normal saline was injected in the greater palatine foramen	Procedure: Sphenopalatine 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.
Active Comparator: Group B (Bupivacaine group) (n= 35); 1.5 ml of Bupivacaine was injected in the greater palatine foramen.	Procedure: Sphenopalatine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Cysts; Mucinoses; Ganglion Cysts; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: FMASU MS221/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No