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Opioid Free Versus Opioid Based General Anesthesia in Septoplasty Under Nociception Level Guidance

Opioid Free Versus Opioid Based General Anesthesia in Septoplasty Under Nociception Level Guidance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07786727
Enrollment
150
Registered
2026-08-26
Start date
2024-01-01
Completion date
2025-06-30
Last updated
2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deviated Septum, Opioid Free Anesthesia

Brief summary

Prospactive observational Clinical study

Interventions

OTHEROFA

OFA

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 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 2.

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Opioid-Free Versus Opioid-Based Anesthesia on Postoperative Pain and Recovery in Patients Undergoing Septal Surgery18 monthsPrimary 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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026