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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT06785350
Eligibility Criteria:
Inclusion Criteria:
Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).
Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.
Exclusion Criteria:
Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\<15kg/m2 or\>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \< 15 before surgery. Unable to provide written informed consent.
Withdrawal criteria:
Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.
Reoperation during follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06785350
Study Brief:
Protocol Section:
NCT06785350