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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT07049094
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* ASA I-III
* Scheduled for elective cranial surgery
* Informed consent from the patient or legal representative
Exclusion Criteria:
* Preoperative Glasgow score \< 15
* Preoperative headache with NRS ≥ 4
* Anticipated postoperative sedation or extubation difficulties requiring mechanical ventilation
* Inability to understand the numerical rating scale (NRS)
* Allergies or contraindications to amide local anesthetics, opioids, or NSAIDs
* Long-term opioid or corticosteroid treatment (\> 2 weeks)
* History of drug abuse in the past 2 years
* Daily alcohol consumption exceeding 3 standard doses
* Mental or cognitive disorders affecting perioperative assessment
* Contraindications for nerve blocks, including infection or tumors at the puncture site, diagnosed diabetic peripheral neuropathy, or inability to cooperate
* Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis preoperatively), or severe heart failure (METS \< 4)
* Pregnant or breastfeeding women
* History of craniotomy or pre-existing pathological pain conditions (e.g., migraines, trigeminal neuralgia)
* Incisions for craniotomy extending beyond the area covered by the scalp nerve blocks
* Participation in other clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07049094
Study Brief:
Protocol Section:
NCT07049094