Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT00454259
Eligibility Criteria:
Inclusion Criteria:
In both groups:
* 18-40 years old male volunteer
* Weight: 60 to 85 kg
* ASA score: 1
* Informed consent obtained from the patient
In "operated" group:
* At least one history of peripheral surgery under general anesthesia with opioid in the past five years.
Exclusion Criteria:
In both groups:
* The patients do not accept inclusion to the study
* Drug or alcohol abuse history
* Chronic use of analgesic drugs or history of chronic pain
* Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection
* Neurological and/or psychiatric disorder, inability to give informed consent
* Psychological trauma within the two year preceding the inclusion
* Any contraindication to fentanyl use
* Use of any medication interacting with fentanyl
* Exclusion period from the national healthy volunteer register
In "healthy" group:
* Any history of general anesthesia or surgery
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00454259
Study Brief:
Protocol Section:
NCT00454259