Trans-nasal Sphenopalatine Ganglion Block for Prevention of Emergence Agitation Following Functional Endoscopic Sinus Surgery

NCT07645521 | Completed

• 1 other identifier: ANES-FESS-SPGB-2026-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.

Conditions

Chronic Rhinosinusitis (CRS); Emergence Agitation

Keywords

Functional Endoscopic Sinus Surgery; FESS; Sphenopalatine Ganglion Block; SPGB; Trans-nasal Sphenopalatine Ganglion Block; Emergence Agitation; Randomized Controlled Trial; Postoperative Pain; Sinonasal Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Emergence Agitation

  Incidence of emergence agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +2 at any time during the first 30 minutes in the post-anesthesia care unit (PACU).

  first 30 minutes in the post-anesthesia care unit (PACU).

Secondary Outcomes (7)

• Postoperative Pain Scores

  first 30 minutes in the post-anesthesia care unit (PACU)

• Postoperative Fentanyl Consumption

  first 30 minutes in the post-anesthesia care unit (PACU)

• Mean Arterial Blood Pressure

  From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)

• Heart Rate

  From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)

• Incidence of Postoperative Nausea and Vomiting

  first 30 minutes in the post-anesthesia care unit (PACU)

Study Arms (2)

Experimental Group (SPGB)

EXPERIMENTAL

Bilateral trans-nasal SPGB performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side.

Procedure: Bilateral Trans-nasal Sphenopalatine Ganglion Block

Placebo Comparator Group (C)

PLACEBO COMPARATOR

Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL normal saline per side.

Procedure: Sham Trans-nasal Injection

Interventions

Sham Trans-nasal Injection PROCEDURE

Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side.

Also known as: Placebo Injection, Sham Procedure, Sham Sphenopalatine Ganglion Block

Placebo Comparator Group (C)

Bilateral Trans-nasal Sphenopalatine Ganglion Block PROCEDURE

Bilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side.

Also known as: Endoscopic Sphenopalatine Ganglion Block, SPGB

Experimental Group (SPGB)

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years.
• ASA physical status I-II.
• Scheduled for elective FESS under general anesthesia.

You may not qualify if:

• ASA physical status III or higher.
• Known allergy or contraindication to local anesthetics.
• Coagulopathy or anticoagulant therapy.
• Psychiatric illness or cognitive impairment affecting agitation assessment.
• Chronic opioid use or substance abuse.
• Pregnancy or lactation.
• Revision nasal surgery or anatomical abnormalities preventing SPGB.
• Intraoperative complications requiring deviation from the study protocol.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (4)

• Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.

  PMID: 21739090 BACKGROUND

• Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3.

  PMID: 33388988 BACKGROUND

• Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9.

  PMID: 30296912 BACKGROUND

• Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2.

  PMID: 39366653 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Officials

• Amir Mostafa Shabana, MD

  Faculty of Medicine, Mansoura University, Mansoura, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study solution was prepared in identical syringes by a scrub nurse who was not involved in patient management, outcome assessment, data collection, or statistical analysis. Participants, the surgeon performing the block and surgery, the attending anesthesiologist, outcome assessors, investigators, and the statistician remained blinded to treatment allocation throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 12, 2026
• Study Start: January 5, 2025
• Primary Completion: February 7, 2026
• Study Completion: April 13, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

EG (1)