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OpenTrials
Completed

NCT Number: NCT07786727

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

Prospactive observational Clinical study

Completed

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Key information

Conditions

Deviated Septum Opioid Free Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GH Drama

Drama, Καβάλας, 65403, Greece

Who can participate

Healthy volunteers accepted: Yes

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

  • 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

Treatment and study plan

OFA

Other

OFA

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

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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