Sphenopalatine Ganglion Block in Septorhinoplasty

December 4, 2023 updated by: Suheda Akbulut, Istanbul Medeniyet University

The Effect of Sphenopalatine Ganglion Block on Intraoperative Remifentanil Consumption and Postoperative Pain in Septorhinoplasty Surgery

Septorhinoplasty is a widely performed surgery that aims to correct both functional and aesthetic problems of the nose. Despite its expected clinical benefits, septorhinoplasty surgery causes postoperative pain, which affects the patient's functional recovery and satisfaction. Opioids, Non-steroidal anti-inflammatory drugs (NSAII), acetaminophen and local anesthetics are used in peroperative pain management in septorhinoplasty. Sphenopalatine ganglion block (SPGB), which has been recently described and has different application areas, is a regional analgesia technique that has been investigated for this purpose. Although there are studies on postoperative pain in septorhinoplasty surgeries, there are not enough studies on its effects on intraoperative pain.

This study may have positive effects on appropriate pain management, patient comfort and surgical outcomes as multimodal analgesia management in septorhinoplasty surgeries, and may make significant contributions to evidence-based practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

  • Turkey
      • Istanbul, Turkey
        • Suheda Akbulut

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

Sampling Method

Probability Sample

Study Population

Patients who operated for septorhinoplasty

Description

Inclusion Criteria:

  • Undergoing septorhinoplasty surgery
  • Ages between 18-65
  • ASA (American Society of Anesthesiologists) score I-II

Exclusion Criteria:

  • Unavailable postoperative pain scores and analgesic use in the hospital registry system
  • Local anesthetic drug allergy and toxicity
  • Advanced organ failure
  • Mental retardation

Patients who are pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Block Group
After intubation, the plastic part of the 18G angioket is placed transnasally into both nostrils in the supine position of the patients who will undergo sphenopalatine ganglion block, with the head in 15-20° extension and is advanced until it contacts the posterior mucosa. After contact, withdraw 1 mm and apply 0.5% bupivacaine 2 ml by dropping into the postnasal space within 1 minute.
Procedure: Sphenopalatine Ganglion Block
For SPGB, the plastic part of the 16G angiogram is advanced transnasally into both nostrils, with the patient in the supine position and the head in 15-20° extension, until it contacts the posterior mucosa, and after contact, it is withdrawn 1 mm and 2 ml of 0.5% bupivacaine is dripped into the postnasal space within 1 minute. is applied.
Control Group
Group of patients who did not undergo sphenopalatine gangion block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
remifentanil consumption
Time Frame: 2 hours
microgram
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale
Time Frame: 15 minute, 30 minute, 1hour, 2 hour, 4 hour, 8 hour,16 hour, 24 hour
Minimum values=1 and Maximum value=10. Highest values are worse outcome.
15 minute, 30 minute, 1hour, 2 hour, 4 hour, 8 hour,16 hour, 24 hour

Collaborators and Investigators

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

Sponsor

Istanbul Medeniyet 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)

June 7, 2023

Primary Completion (Actual)

August 21, 2023

Study Completion (Actual)

August 21, 2023

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedeniyetUniverstySAkbulut001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Pain, Postoperative

Clinical Trials on Sphenopalatine Ganglion Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe