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

NCT06847425 | Completed

• 1 other identifier: FMASU MS221/2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to first rescue analgesia

  24 hours postoperatively

• Total requirements of rescue analgesia

  24 hours postoperatively

• Number of patients receiving rescue analgesia

  24 hours postoperatively

• Incidence and severity of adverse effects and complications

  24 hours postoperatively

Study Arms (2)

Group A (control group) (n= 35 )

ACTIVE COMPARATOR

1.5 ml of normal saline was injected in the greater palatine foramen

Procedure: Sphenopalatine Ganglion Block trans oral approach saline injection

Group B (Bupivacaine group) (n= 35)

ACTIVE COMPARATOR

1.5 ml of Bupivacaine was injected in the greater palatine foramen.

Procedure: Sphenopalatine ganglion block trans oral approach bupivacaine injection

Interventions

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.

Group A (control group) (n= 35 )

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.

Group B (Bupivacaine group) (n= 35)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years - 80 years.
• ASA I and ASA II patients.
• Consented to participate in the research.

You may not qualify if:

• Pregnant and breastfeeding females.
• History of allergy to bupivacaine or other local anaesthetics.
• Patients with uncontrolled hypertension, poorly controlled cardiovascular diseases, or cerebrovascular diseases.
• Patients with pre-existing neurological conditions.
• Patients with history of alcohol or drug abuse.
• Patients on anticoagulation.
• Occurrence of surgical or anaesthetic complications or change in the anaesthesia protocol.
• Patients showing sensitivity to Bupivacaine.
• Patients unable to understand VAS score.
• Patients refusing to continue participating in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 20, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-01

Locations

EG (1)