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

NCT ID: NCT06016816

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2024-02-02

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia of Mucous Membrane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Endoscopic bilateral sphenopalatine ganglion block

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

Group Type ACTIVE_COMPARATOR

Bilateral endoscopic sphenopalatine ganglion block

Intervention Type PROCEDURE

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type PROCEDURE

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

Interventions

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Bilateral endoscopic sphenopalatine ganglion block

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

Intervention Type PROCEDURE

placebo

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hülya Tosun Söner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HTosunSoner

Identifier Type: -

Identifier Source: org_study_id

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