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

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06016816
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 14.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia of Mucous Membrane	Procedure: Bilateral endoscopic sphenopalatine ganglion block; Procedure: placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale [Postoperative 0-2 hours, 2-8 hours,8-24 hours]

   They will be numbered from 1 to 10. 1 mildest 10 most severe pain

Secondary Outcome Measures

1. Riker Agitation Scale [Immediately after extubation]

   7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A 1 Unarousable

2. mean arterial pressure [when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation]

   mmhg

3. heart rate [when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation]

   beats\minute

4. intraoperative remifentanil consumption [intraoperative]

   The intraoperative ultiva infusion dose was recorded to the patient.

5. edema questionnaire [Postoperative 0-2 hours, 2-8 hours,8-24 hours]

   Periorbital edema was evaluated as present or absent questionnaire

6. hematoma questionnaire [Postoperative 0-2 hours, 2-8 hours,8-24 hours]

   Hematoma was evaluated as present or absent questionnaire

7. vomiting questionnaire [Postoperative 0-2 hours, 2-8 hours,8-24 hours]

   was evaluated as present or absent questionnaire

8. Oral analgesic use [In the first 24 hours after surgery]

   Analgesic use in the first 24 hours was questioned.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Sciences University Gazi Yaşargil Training and Research Hospital	Diyarbakır	Kayapınar	Turkey	21070

Sponsors and Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hülya Tosun Söner, Principal Investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT06016816
• Other Study ID Numbers: HTosunSoner
• First Posted: Aug 30, 2023
• Last Update Posted: Aug 30, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hülya Tosun Söner, Principal Investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: sphenopalatine ganglion block; septhorhinoplasty; general anesthesia
• Additional relevant MeSH terms: Ganglion Cysts; Pain, Postoperative

Study Results

No Results Posted as of Aug 30, 2023