Opioid Sparing Effect of Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: a Randomized Controlled Clinical Trial.

December 22, 2024 updated by: Ahmed Mohamed Ali Ismaeil, Assiut University

Functional endoscopic sinus surgery (FESS) is widely recognized as a safe and preferred treatment option for various conditions, particularly nasal polyps and rhinosinusitis . This technique has been shown to improve postoperative symptoms by 86.3% in patients with chronic inflammatory paranasal sinus diseases .

The aim of this study is to evaluate the effect of adding of MgSO4 to bupivacaine via SPGB block for postoperative pain for 24 hours in patients scheduled for FESS as opioid free anaesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

However, managing postoperative pain remains a significant challenge. Research suggests that 86% of surgical patients experience pain, with 75% enduring moderate to severe levels .

The Sphenopalatine Ganglion Block (SPGB) is an effective, safe, and well-tolerated method for managing craniofacial pain. The ganglion comprises both sensory and autonomic nerves, which innervate the nasal cavity, palate, and certain areas of the nasopharynx and oropharynx . SPGB involves the administration of analgesic agents into the nasal cavity, typically through an endoscopic approach due to the challenges of transnasal injection . Some complications, such as postoperative nosebleeds, and temporary numbness of the palate, have been observed following the blockade with endoscopic intervention, but these are generally temporary .

Studies evaluating the effects of the sphenopalatine block in endoscopic sinus surgery suggest that patients who received the ganglion block experienced reduced postoperative pain compared to those in the placebo group when combined with general anaesthesia .

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Patients programmed for elective FESS

    • American society of anaesthesiologists (ASA) physical state I-II
    • Age over 18 years and less than 60-years-old.

Exclusion Criteria:

  • • Known hypersensitivity to the study drugs.

    • Inability to accurately describe postoperative pain to investigators.
    • Opioid tolerance or dependence.
    • Patient refusal
    • History of renal, liver, cardiac, neuropsychiatric disorder problems.
    • Bleeding or coagulation abnormality.
    • Infection at the site of injection

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
patients will receive SPGB block with 2 ml volume on each side (1.5 mL of bupivacaine 0.5% + 0.5 mL of magnesium sulphate 10%)
Drug: Bupivacaine
patients will receive SPGB block with 2 ml volume on each side (1.5 mL of bupivacaine 0.5% + 0.5 mL of magnesium sulphate 10%).
Drug: Magnesium Sulphate 500 mg
patients will receive SPGB block with 2 ml volume on each side (1.5 ml bupivacaine 0.5% plus 0.5 ml saline).
Experimental: group B
patients will receive SPGB block with 2 ml volume on each side (1.5 ml bupivacaine 0.5% plus 0.5 ml saline).
Drug: Bupivacaine
patients will receive SPGB block with 2 ml volume on each side (1.5 mL of bupivacaine 0.5% + 0.5 mL of magnesium sulphate 10%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain according to (NRS)
Time Frame: 24 hours
The effect of adding of MgSO4 to bupivacaine via SPGB block for postoperative pain according to (NRS) for 24 hours in patients scheduled for FESS
24 hours

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPGB sinus surgery

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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