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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT05693467
Eligibility Criteria:
Inclusion Criteria:
* Age 18-64 years;
* Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
* American Society of Anesthesiologists (ASA) physical status of I-III;
* Anticipated full recovery and cooperation within 2 hours postoperatively.
Exclusion Criteria:
* History of spinal surgery;
* Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
* Body mass index (BMI)\<15kg/m2 or \>35kg/m2;
* Peri-incisional infection;
* History of diabetes mellitus and other metabolic diseases;
* History of severe cardiopulmonary, hepatic or renal dysfunction;
* Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value);
* History of allergies to any of the study drugs;
* History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery;
* Use of systemic steroids within 1 week before surgery;
* History of psychiatric disorders, chronic neck or back pain;
* History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively;
* Pregnant or breastfeeding;
* Refusal to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05693467
Study Brief:
Protocol Section:
NCT05693467