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

Primary Purpose

Anesthesia of Mucous Membrane

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral endoscopic sphenopalatine ganglion block
placebo
Sponsored by
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia of Mucous Membrane focused on measuring sphenopalatine ganglion block, septhorhinoplasty, general anesthesia

Eligibility Criteria

17 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Health Sciences University Gazi Yaşargil Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Endoscopic bilateral sphenopalatine ganglion block

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Riker Agitation Scale
7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A 1 Unarousable
mean arterial pressure
mmhg
heart rate
beats\minute
intraoperative remifentanil consumption
The intraoperative ultiva infusion dose was recorded to the patient.
edema questionnaire
Periorbital edema was evaluated as present or absent questionnaire
hematoma questionnaire
Hematoma was evaluated as present or absent questionnaire
vomiting questionnaire
was evaluated as present or absent questionnaire
Oral analgesic use
Analgesic use in the first 24 hours was questioned.

Full Information

First Posted
August 11, 2023
Last Updated
August 29, 2023
Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06016816
Brief Title
The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery
Official Title
The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia of Mucous Membrane
Keywords
sphenopalatine ganglion block, septhorhinoplasty, general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic bilateral sphenopalatine ganglion block
Arm Type
Active Comparator
Arm Description
After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.
Intervention Type
Procedure
Intervention Name(s)
Bilateral endoscopic sphenopalatine ganglion block
Intervention Description
After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,
Intervention Type
Procedure
Intervention Name(s)
placebo
Intervention Description
Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Description
They will be numbered from 1 to 10. 1 mildest 10 most severe pain
Time Frame
Postoperative 0-2 hours, 2-8 hours,8-24 hours
Secondary Outcome Measure Information:
Title
Riker Agitation Scale
Description
7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A 1 Unarousable
Time Frame
Immediately after extubation
Title
mean arterial pressure
Description
mmhg
Time Frame
when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
Title
heart rate
Description
beats\minute
Time Frame
when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
Title
intraoperative remifentanil consumption
Description
The intraoperative ultiva infusion dose was recorded to the patient.
Time Frame
intraoperative
Title
edema questionnaire
Description
Periorbital edema was evaluated as present or absent questionnaire
Time Frame
Postoperative 0-2 hours, 2-8 hours,8-24 hours
Title
hematoma questionnaire
Description
Hematoma was evaluated as present or absent questionnaire
Time Frame
Postoperative 0-2 hours, 2-8 hours,8-24 hours
Title
vomiting questionnaire
Description
was evaluated as present or absent questionnaire
Time Frame
Postoperative 0-2 hours, 2-8 hours,8-24 hours
Title
Oral analgesic use
Description
Analgesic use in the first 24 hours was questioned.
Time Frame
In the first 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Health Sciences University Gazi Yaşargil Training and Research Hospital
City
Diyarbakır
State/Province
Kayapınar
ZIP/Postal Code
21070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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