Sphenopalatine Ganglion Block in Septorhinoplasty

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06157970
• Other study ID #: MedeniyetUniverstySAkbulut001
• Status: Completed
• Start date: June 7, 2023
• Est. completion date: August 21, 2023

Study information

• Verified date: December 2023
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Rhinoplasty

Intervention

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.

Locations

Country	Name	City	State
Turkey	Suheda Akbulut	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remifentanil consumption	microgram	2 hours
Secondary	Numerical Rating Scale	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