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

N/ACompletedNCT07786727

Democritus University of Thrace150 enrolled

Overview

Prospactive observational Clinical study

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Deviated Septum Opioid Free Anesthesia

Interventions

OFAOTHER

OFA

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GH Drama

Drama, Καβάλας, Greece

Outcomes

Primary Outcomes

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

Time frame: 18 months

Data from ClinicalTrials.gov

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