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

Anesthesia of Mucous Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016816
• Other study ID #: HTosunSoner
• Status: Completed
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: February 2, 2024

Study information

• Verified date: February 2024
• Source: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia of Mucous Membrane
• Ganglion Cysts
• Pain, Postoperative

Intervention

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
Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.

Locations

Country	Name	City	State
Turkey	Health Sciences University Gazi Yasargil Training and Research Hospital	Diyarbakir	Kayapinar

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	mean arterial pressure	mmhg	when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
Secondary	heart rate	beats\minute	when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
Secondary	intraoperative remifentanil consumption	The intraoperative ultiva infusion dose was recorded to the patient.	intraoperative
Secondary	edema questionnaire	Periorbital edema was evaluated as present or absent questionnaire	Postoperative 0-2 hours, 2-8 hours,8-24 hours
Secondary	hematoma questionnaire	Hematoma was evaluated as present or absent questionnaire	Postoperative 0-2 hours, 2-8 hours,8-24 hours
Secondary	vomiting questionnaire	was evaluated as present or absent questionnaire	Postoperative 0-2 hours, 2-8 hours,8-24 hours
Secondary	Oral analgesic use	Analgesic use in the first 24 hours was questioned.	In the first 24 hours after surgery