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

NCT06016816 | Completed

• 1 other identifier: HTosunSoner
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia of Mucous Membrane

Keywords

sphenopalatine ganglion block; septhorhinoplasty; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Riker Agitation Scale

  Immediately after extubation

• mean arterial pressure

  when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation

• heart rate

  when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation

• intraoperative remifentanil consumption

  intraoperative

• edema questionnaire

  Postoperative 0-2 hours, 2-8 hours,8-24 hours

Study Arms (2)

Endoscopic bilateral sphenopalatine ganglion block

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Procedure: placebo

Interventions

Bilateral endoscopic sphenopalatine ganglion block PROCEDURE

After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,

Endoscopic bilateral sphenopalatine ganglion block

placebo PROCEDURE

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

Placebo

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 30, 2023
• Study Start: January 9, 2024
• Primary Completion: February 1, 2024
• Study Completion: February 2, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)