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Completed

NCT Number: NCT06016816

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

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.

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Key information

Conditions

Anesthesia of Mucous Membrane

Age range

17 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University Gazi Yaşargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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,

Placebo

Procedure

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

Primary outcomes

  1. Numeric Rating Scale

    Time frame: 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 outcomes

  1. Riker Agitation Scale

    Time frame: 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

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

    mmhg

  3. heart rate

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

    beats\\minute

  4. intraoperative remifentanil consumption

    Time frame: intraoperative

    The intraoperative ultiva infusion dose was recorded to the patient.

  5. edema questionnaire

    Time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours

    Periorbital edema was evaluated as present or absent questionnaire

  6. hematoma questionnaire

    Time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours

    Hematoma was evaluated as present or absent questionnaire

  7. vomiting questionnaire

    Time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours

    was evaluated as present or absent questionnaire

  8. Oral analgesic use

    Time frame: In the first 24 hours after surgery

    Analgesic use in the first 24 hours was questioned.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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