Sphenopalatine Ganglion Block in Septorhinoplasty

NCT06157970 | Completed

• 1 other identifier: MedeniyetUniverstySAkbulut001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Rhinoplasty

Outcome Measures

Primary Outcomes (1)

• remifentanil consumption

  microgram

  2 hours

Secondary Outcomes (1)

• Numerical Rating Scale

  15 minute, 30 minute, 1hour, 2 hour, 4 hour, 8 hour,16 hour, 24 hour

Study Arms (2)

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

Control Group

Group of patients who did not undergo sphenopalatine gangion block

Interventions

Sphenopalatine Ganglion Block PROCEDURE

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the supine position and the head in 15-20° extension, until it contacts the posterior mucosa, and after contact, it is withdrawn 1 mm and 2 ml of 0.5% bupivacaine is dripped into the postnasal space within 1 minute.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.

Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who operated for septorhinoplasty

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Suheda Akbulut

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 6, 2023
• Study Start: June 7, 2023
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)