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

June 11, 2026 updated by: Mansoura University

Effect of Bilateral Trans-nasal Sphenopalatine Ganglion Block on Emergence Agitation Following Functional Endoscopic Sinus Surgery: A Double-Blind Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt
        • Mansoura University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 18-65 years.
  • ASA physical status I-II.
  • Scheduled for elective FESS under general anesthesia.
  • Ability to provide informed consent. Exclusion Criteria
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (SPGB)
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
Bilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side.
Other Names:
  • SPGB
  • Endoscopic Sphenopalatine Ganglion Block
Placebo Comparator: Placebo Comparator Group (C)
Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL normal saline per side.
Procedure: Sham Trans-nasal Injection
Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side.
Other Names:
  • Sham Procedure
  • Placebo Injection
  • Sham Sphenopalatine Ganglion Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Emergence Agitation
Time Frame: first 30 minutes in the post-anesthesia care unit (PACU).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores
Time Frame: first 30 minutes in the post-anesthesia care unit (PACU)
Pain intensity assessed using the Visual Analog Scale (VAS).
first 30 minutes in the post-anesthesia care unit (PACU)
Postoperative Fentanyl Consumption
Time Frame: first 30 minutes in the post-anesthesia care unit (PACU)
Total postoperative fentanyl requirement administered for rescue analgesia.
first 30 minutes in the post-anesthesia care unit (PACU)
Mean Arterial Blood Pressure
Time Frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Intraoperative and postoperative mean arterial blood pressure measurements.
From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Heart Rate
Time Frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Intraoperative and postoperative heart rate measurements.
From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Incidence of Postoperative Nausea and Vomiting
Time Frame: first 30 minutes in the post-anesthesia care unit (PACU)
Occurrence of postoperative nausea and/or vomiting.
first 30 minutes in the post-anesthesia care unit (PACU)
Adverse Events
Time Frame: From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Procedure-related complications including epistaxis, local anesthetic systemic toxicity, diplopia or visual symptoms, palatal numbness, and other adverse events.
From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU)
Duration of Surgery
Time Frame: During surgery
Total operative time measured from surgical incision to completion of surgery.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Amir Mostafa Shabana, MD, Faculty of Medicine, Mansoura University, Mansoura, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2025

Primary Completion (Actual)

February 7, 2026

Study Completion (Actual)

April 13, 2026

Study Registration Dates

First Submitted

June 7, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES-FESS-SPGB-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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