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

March 6, 2025 updated by: Ain Shams University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Cairo, Egypt
        • Ain shams university

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A (control group) (n= 35 )
1.5 ml of normal saline was injected in the greater palatine foramen
Procedure: Sphenopalatine Ganglion Block trans oral approach saline injection
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.
Active Comparator: Group B (Bupivacaine group) (n= 35)
1.5 ml of Bupivacaine was injected in the greater palatine foramen.
Procedure: Sphenopalatine ganglion block trans oral approach bupivacaine injection
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Visual Analogue Scale (VAS) pain score over the first 24 hours postoperatively.
Time Frame: in the PACU, at 2, 6, 12, and 24 hours after surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesia
Time Frame: 24 hours postoperatively
Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesic and the time to the first rescue analgesia will be recorded
24 hours postoperatively
Total requirements of rescue analgesia
Time Frame: 24 hours postoperatively
Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesia
24 hours postoperatively
Number of patients receiving rescue analgesia
Time Frame: 24 hours postoperatively
Participants with VAS score ≥4 at any point of time and complaining of pain will receive fentanyl (25-50 μg) as a rescue analgesic.
24 hours postoperatively
Incidence and severity of adverse effects and complications
Time Frame: 24 hours postoperatively
Incidence and severity of adverse effects and complications such as nausea and vomiting (PONV), headache, visual disturbances, sore throat and swallowing difficulty during the first 24 hours postoperatively
24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MS221/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings