Anesthesia of Mucous MembraneNCT06016816
The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery
A study testing Bilateral endoscopic sphenopalatine ganglion block in people with Anesthesia of Mucous Membrane, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia of Mucous Membrane
- What is being tested?
- Bilateral endoscopic sphenopalatine ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2024to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gazi Yaşargil Training and Research Hospital
Diyarbakır, Kayapınar, 21070
About this study
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
- Being tested
- Bilateral endoscopic sphenopalatine ganglion block, placebo
- Keywords
- sphenopalatine ganglion block, septhorhinoplasty, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral endoscopic sphenopalatine ganglion blockProcedure or surgery
After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,
placeboProcedure or surgery
Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Procedure: Bilateral endoscopic sphenopalatine ganglion block |
| Placebo | Placebo comparator | Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated. Receives: Procedure: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
They will be numbered from 1 to 10.
1 mildest 10 most severe pain
Measured: Postoperative 0-2 hours, 2-8 hours,8-24 hours
Secondary outcomes (8)
Riker Agitation Scale
7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A
1 Unarousable
Measured: Immediately after extubation
mean arterial pressure
mmhg
Measured: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
heart rate
beats\minute
Measured: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
intraoperative remifentanil consumption
The intraoperative ultiva infusion dose was recorded to the patient.
Measured: intraoperative
edema questionnaire
Periorbital edema was evaluated as present or absent questionnaire
Measured: Postoperative 0-2 hours, 2-8 hours,8-24 hours
hematoma questionnaire
Hematoma was evaluated as present or absent questionnaire
Measured: Postoperative 0-2 hours, 2-8 hours,8-24 hours
vomiting questionnaire
was evaluated as present or absent questionnaire
Measured: Postoperative 0-2 hours, 2-8 hours,8-24 hours
Oral analgesic use
Analgesic use in the first 24 hours was questioned.
Measured: In the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start9 Jan 2024
- Primary completion1 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia of Mucous MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016816
- Sponsor's protocol ID
- HTosunSoner
- Status last verified
- Feb 2024
- First submitted
- 11 Aug 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery
- ClinicalTrials.gov ID
- NCT06016816
- Acronym / sponsor ID
- HTosunSoner
- Conditions
- Anesthesia of Mucous Membrane
- Keywords
- sphenopalatine ganglion block, septhorhinoplasty, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic bilateral sphenopalatine ganglion block | Active comparator | Procedure: Bilateral endoscopic sphenopalatine ganglion blockAfter the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, |
| Placebo | Placebo comparator | Procedure: placeboPlacebo group (group:2) will be administered 4 cc saline. aspects will be evaluated. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral endoscopic sphenopalatine ganglion blockAfter the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, | Procedure or surgery | Endoscopic bilateral sphenopalatine ganglion block |
| placeboPlacebo group (group:2) will be administered 4 cc saline. aspects will be evaluated. | Procedure or surgery | Placebo |
Primary outcome
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
8 secondary outcomes
Riker Agitation Scale
Time frame: Immediately after extubation
mean arterial pressure
Time frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
heart rate
Time frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
intraoperative remifentanil consumption
Time frame: intraoperative
edema questionnaire
Time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
hematoma questionnaire
Time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
vomiting questionnaire
Time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
Oral analgesic use
Time frame: In the first 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Anesthesia of Mucous Membrane
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingPhase 3
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
ENT Disorder, Nasal Procedures
Not yet recruiting
ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation
Bacterial Transmission, Intubation Intratracheal
Recruiting
Comparison of Conventional Buccal Nerve Block Versus Buccal Nerve Trunk Block During Extraction of Posterior Mandibular Teeth
Pain (Visceral, Somatic, or Neuropathic)
Not yet recruiting
Insertion of a Transoesophageal Echocardiography Probe Using McGRATH
Echocardiography, Transesophageal, Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral endoscopic sphenopalatine ganglion block in people with Anesthesia of Mucous Membrane, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.