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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT06488768
Eligibility Criteria:
Inclusion criteria for opioid group
* Age \> 18 years old
* ASA 1-3
* Chronic pain, defined as persisting pain for more than three months
* Daily use of more than 60 mg of morphine equivalent in more than 7 days
* Legally competent and able to give informed consent
Inclusion criteria for the opioid naive control group
* Age \> 18 years old
* ASA 1-3
* No use of opioids within 30 days prior to participation
* Legally competent and able to give informed consent
Exclusion Criteria:
* Age \> 84 years old
* Volunteers who cannot cooperate with the study
* Volunteers who cannot understand or speak Danish
* Allergy to the lidocaine or the preservatives used in the study
* Alcohol or drug abuse other than opioids
* Peripheral neuropathy at the upper limb non-dominant arm
* Pathology or previous major surgery to the upper limb
* Active signs of infection in the cutaneous area of injection
* Pregnancy at the time of the trial
* Partial or complete 2nd or 3rd degree atrioventricular heart block without a pacemaker
* Severe liver disease
* Severe kidney disease and reduced kidney function (eGFR below 30 mL/min)
* Daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive
* Daily treatment with class III antiarrhythmics e.g., amiodarone.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT06488768
Study Brief:
Protocol Section:
NCT06488768