Pain, PostoperativeNCT06157970
Sphenopalatine Ganglion Block in Septorhinoplasty
An observational study of Pain, Postoperative and Rhinoplasty, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Septorhinoplasty is a widely performed surgery that aims to correct both functional and aesthetic problems of the nose. Despite its expected clinical benefits, septorhinoplasty surgery causes postoperative pain, which affects the patient's functional recovery and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Rhinoplasty
- What is being tested?
- Sphenopalatine Ganglion Block
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2023to 21 Aug 2023
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who operated for septorhinoplasty
Who may be able to join
- Undergoing septorhinoplasty surgery
- Ages between 18-65
- ASA (American Society of Anesthesiologists) score I-II
Who cannot join
- Unavailable postoperative pain scores and analgesic use in the hospital registry system
- Local anesthetic drug allergy and toxicity
- Advanced organ failure
- Mental retardation
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sphenopalatine Ganglion Block on Intraoperative Remifentanil Consumption and Postoperative Pain in Septorhinoplasty Surgery
Septorhinoplasty is a widely performed surgery that aims to correct both functional and aesthetic problems of the nose. Despite its expected clinical benefits, septorhinoplasty surgery causes postoperative pain, which affects the patient's functional recovery and satisfaction. Opioids, Non-steroidal anti-inflammatory drugs (NSAII), acetaminophen and local anesthetics are used in peroperative pain management in septorhinoplasty. Sphenopalatine ganglion block (SPGB), which has been recently described and has different application areas, is a regional analgesia technique that has been investigated for this purpose. Although there are studies on postoperative pain in septorhinoplasty surgeries, there are not enough studies on its effects on intraoperative pain.
This study may have positive effects on appropriate pain management, patient comfort and surgical outcomes as multimodal analgesia management in septorhinoplasty surgeries, and may make significant contributions to evidence-based practices.
- Conditions
- Pain, Postoperative, Rhinoplasty
- Being tested
- Sphenopalatine Ganglion Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockProcedure or surgery
For SPGB, the plastic part of the 16G angiogram is advanced transnasally into both nostrils, with the patient in the supine position and the head in 15-20° extension, until it contacts the posterior mucosa, and after contact, it is withdrawn 1 mm and 2 ml of 0.5% bupivacaine is dripped into the postnasal space within 1 minute. is applied.
| Study group | Role | What they receive |
|---|---|---|
| Block Group | After intubation, the plastic part of the 18G angioket is placed transnasally into both nostrils in the supine position of the patients who will undergo sphenopalatine ganglion block, with the head in 15-20° extension and is advanced until it contacts the posterior mucosa. After contact, withdraw 1 mm and apply 0.5% bupivacaine 2 ml by dropping into the postnasal space within 1 minute. Receives: Procedure: Sphenopalatine Ganglion Block | |
| Control Group | Group of patients who did not undergo sphenopalatine gangion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
remifentanil consumption
microgram
Measured: 2 hours
Secondary outcomes (1)
Numerical Rating Scale
Minimum values=1 and Maximum value=10. Highest values are worse outcome.
Measured: 15 minute, 30 minute, 1hour, 2 hour, 4 hour, 8 hour,16 hour, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start7 Jun 2023
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suheda Akbulut, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157970
- Sponsor's protocol ID
- MedeniyetUniverstySAkbulut001
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2023
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sphenopalatine Ganglion Block on Intraoperative Remifentanil Consumption and Postoperative Pain in Septorhinoplasty Surgery
- ClinicalTrials.gov ID
- NCT06157970
- Acronym / sponsor ID
- MedeniyetUniverstySAkbulut001
- Conditions
- Pain, Postoperative, Rhinoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 6 Dec 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.
Septorhinoplasty is a widely performed surgery that aims to correct both functional and aesthetic problems of the nose. Despite its expected clinical benefits, septorhinoplasty surgery causes postoperative pain, which affects the patient's functional recovery and satisfaction. Opioids, Non-steroidal anti-inflammatory drugs (NSAII), acetaminophen and local anesthetics are used in peroperative pain management in septorhinoplasty. Sphenopalatine ganglion block (SPGB), which has been recently described and has different application areas, is a regional analgesia technique that has been investigated for this purpose. Although there are studies on postoperative pain in septorhinoplasty surgeries, there are not enough studies on its effects on intraoperative pain.
This study may have positive effects on appropriate pain management, patient comfort and surgical outcomes as multimodal analgesia management in septorhinoplasty surgeries, and may make significant contributions to evidence-based practices.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block Group | – | Procedure: Sphenopalatine Ganglion BlockAfter intubation, the plastic part of the 18G angioket is placed transnasally into both nostrils in the supine position of the patients who will undergo sphenopalatine ganglion block, with the head in 15-20° extension and is advanced until it contacts the posterior mucosa. After contact, withdraw 1 mm and apply 0.5% bupivacaine 2 ml by dropping into the postnasal space within 1 minute. |
| Control Group | – | –Group of patients who did not undergo sphenopalatine gangion block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who operated for septorhinoplasty
Key inclusion criteria (3 listed)
- Undergoing septorhinoplasty surgery
- Ages between 18-65
- ASA (American Society of Anesthesiologists) score I-II
Key exclusion criteria (5 listed)
- Unavailable postoperative pain scores and analgesic use in the hospital registry system
- Local anesthetic drug allergy and toxicity
- Advanced organ failure
- Mental retardation
- Patients who are pregnant
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 |
|---|---|---|
| Sphenopalatine Ganglion BlockFor SPGB, the plastic part of the 16G angiogram is advanced transnasally into both nostrils, with the patient in the supine position and the head in 15-20° extension, until it contacts the posterior mucosa, and after contact, it is withdrawn 1 mm and 2 ml of 0.5% bupivacaine is dripped into the postnasal space within 1 minute. is applied. | Procedure or surgery | Block Group |
Primary outcome
remifentanil consumption
Time frame: 2 hours
microgram
1 secondary outcome
Numerical Rating Scale
Time frame: 15 minute, 30 minute, 1hour, 2 hour, 4 hour, 8 hour,16 hour, 24 hour
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 6 Dec 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Pain, Postoperative and Rhinoplasty, run by Istanbul Medeniyet University 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 3 inclusion and 5 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 6 Dec 2023. 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. 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?
remifentanil consumption (time frame: 2 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 6 Dec 2023.