The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery

The aim of this study is to examine the effects of bilateral sphenopalatine ganglion block on surgical conditions, hemodynamics, intraoperative and postoperative analgesic use, recovery characteristics, and postoperative pain during septorhinoplasty under general anesthesia. The study was planned as double-blind, randomized, controlled. 72 patients who will undergo septorhinoplasty surgery will be collected. (g power analysis was performed.) Evaluation of the effectiveness of bilateral sphenopalatine ganglion block was planned. Patients will be divided into 2 equal groups (36 patients). After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, the other group (group:2) will be administered 4 cc saline. aspects will be evaluated.

Study Overview

• Status: Completed
• Conditions: Anesthesia of Mucous Membrane
• Intervention / Treatment: Procedure: Bilateral endoscopic sphenopalatine ganglion block; Procedure: placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayapınar
    • Diyarbakır, Kayapınar, Turkey, 21070
      • Health Sciences University Gazi Yaşargil Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- patients with an ASA score of I-II and between the ages of 17-45 years, who were to undergo general anesthesia with desflurane, were included in the study.

Exclusion Criteria:

• Patients aged <17 and >45 years, patients with liver and/or kidney failure, obese patients (BMI >30), trauma patients, ASA III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endoscopic bilateral sphenopalatine ganglion block; After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,	Procedure: Bilateral endoscopic sphenopalatine ganglion block; After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,
Placebo Comparator: Placebo; Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.	Procedure: placebo; Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	They will be numbered from 1 to 10. 1 mildest 10 most severe pain	Postoperative 0-2 hours, 2-8 hours,8-24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Riker Agitation Scale	7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A 1 Unarousable	Immediately after extubation
mean arterial pressure	mmhg	when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
heart rate	beats\minute	when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
intraoperative remifentanil consumption	The intraoperative ultiva infusion dose was recorded to the patient.	intraoperative
edema questionnaire	Periorbital edema was evaluated as present or absent questionnaire	Postoperative 0-2 hours, 2-8 hours,8-24 hours
hematoma questionnaire	Hematoma was evaluated as present or absent questionnaire	Postoperative 0-2 hours, 2-8 hours,8-24 hours
vomiting questionnaire	was evaluated as present or absent questionnaire	Postoperative 0-2 hours, 2-8 hours,8-24 hours
Oral analgesic use	Analgesic use in the first 24 hours was questioned.	In the first 24 hours after surgery

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; sphenopalatine ganglion block; septhorhinoplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Postoperative Complications; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Pain, Postoperative; Ganglion Cysts
• Other Study ID Numbers: HTosunSoner

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