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

NCT07786727 | Completed

• 1 other identifier: 143/2023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospactive observational Clinical study

Conditions

Deviated Septum; Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Study Arms (1)

OFA OBA

Other: OFA

Interventions

OFA OTHER

OFA

OFA OBA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

septoplasty patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

GH Drama

Drama, Καβάλας, 65403, Greece

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rafail Ioannidis, MD/PhD/MSC, Anesthesiologist-Pain Specialist

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)