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

Ain Shams University

Status: Completed

Conditions: Anaesthesia

Treatments: Procedure: Sphenopalatine ganglion block trans oral approach bupivacaine injection; Procedure: Sphenopalatine Ganglion Block trans oral approach saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06847425

FMASU MS221/2024

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Group A (control group) (n= 35 )

Active Comparator group

Description:

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

Treatment:

Procedure: Sphenopalatine Ganglion Block trans oral approach saline injection

Group B (Bupivacaine group) (n= 35)

Active Comparator group

Description:

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

Treatment:

Procedure: Sphenopalatine ganglion block trans oral approach bupivacaine injection