Deviated SeptumNCT07786727
Opioid Free Versus Opioid Based General Anesthesia in Septoplasty Under Nociception Level Guidance
An observational study of Deviated Septum and Opioid Free Anesthesia, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Prospactive observational Clinical study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deviated Septum, Opioid Free Anesthesia
- What is being tested?
- OFA
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2024to 30 Jun 2025
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: septoplasty patients
- Inclusion Criteria:
- Adult patients aged 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-III
- Patients scheduled for elective septal surgery under general anesthesia
- Ability to provide written informed consent
- Ability to understand and use the Numeric Rating Scale (NRS) for postoperative pain assessment
- Exclusion Criteria:
- Patient refusal to participate
- Known allergy or hypersensitivity to any of the study medications
- Contraindication to general anesthesia
- Pre-existing chronic opioid use or chronic pain requiring regular analgesic treatment
- Significant psychiatric or neurological disease that could interfere with postoperative pain assessment
- Inability to understand or reliably report pain using the Numeric Rating Scale
- Pregnancy
- Significant hepatic or renal dysfunction
- Any medical condition considered by the investigators to make participation inappropriate or unsafe
Trial locations and contacts
1 site in 1 country.
About this study
Prospactive observational Clinical study
- Conditions
- Deviated Septum, Opioid Free Anesthesia
- Being tested
- OFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFAOther
OFA
| Study group | Role | What they receive |
|---|---|---|
| OFA OBA | Not described Receives: Other: OFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain and Recovery in Patients Undergoing Septal Surgery
Primary Outcome Measure
Outcome Measure Title:
Postoperative pain intensity measured by the Numeric Rating Scale (NRS) at 15 minutes after surgery
Description:
Postoperative pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at 15 minutes after surgery and will be summarized for each treatment group using mean ± standard deviation or median and interquartile range, as appropriate.
Time Frame:
15 minutes after surgery
Secondary Outcome Measures
Outcome Measure Title:
Postoperative pain intensity measured by the Numeric Rating Scale (NRS) at 1 hour after surgery
Description:
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be summarized for each treatment group using mean ± standard deviation or median and interquartile range, as appropriate.
Time Frame:
1 hour after surge
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deviated SeptumStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafail Ioannidis, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786727
- Sponsor's protocol ID
- 143/2023
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Versus Opioid Based General Anesthesia in Septoplasty Under Nociception Level Guidance
- ClinicalTrials.gov ID
- NCT07786727
- Acronym / sponsor ID
- 143/2023
- Conditions
- Deviated Septum, Opioid Free Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Aug 2026 (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.
Prospactive observational Clinical study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OFA OBA | – | Other: OFA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- septoplasty patients
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 |
|---|---|---|
| OFAOFA | Other | OFA OBA |
Primary outcome
Comparison of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain and Recovery in Patients Undergoing Septal Surgery
Time frame: 18 months
Primary Outcome Measure Outcome Measure Title: Postoperative pain intensity measured by the Numeric Rating Scale (NRS) at 15 minutes after surgery Description: Postoperative pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at 15 minutes after surgery and will be summarized for each treatment group using mean ± standard deviation or median and interquartile range, as appropriate. Time Frame: 15 minutes after surgery Secondary Outcome Measures Outcome Measure Title: Postoperative pain intensity measured by the Numeric Rating Scale (NRS) at 1 hour after surgery Description: Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be summarized for each treatment group using mean ± standard deviation or median and interquartile range, as appropriate. Time Frame: 1 hour after surge
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes
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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 Deviated Septum and Opioid Free Anesthesia, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Aug 2026. 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 Greece. 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?
Comparison of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain and Recovery in Patients Undergoing Septal Surgery (time frame: 18 months). 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 26 Aug 2026.