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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT05461092
Eligibility Criteria:
Inclusion Criteria:
* Are 65 or older
* Indicated for lumbar spinal fusion of less than or equal to 3 levels
* Undergoing elective surgery
* no contraindications to local anesthetic or procedures
* no severe cardiac or respiratory disease
* no preexisting cognitive dysfunction/dementia
Exclusion Criteria:
* 64 years old and younger
* emergency treatment
* pathologic fractures
* seeking revision surgery
* major liver or kidney dysfunction
* coexisting hematological disorder or irreversible abnormal coagulation
* patients with previous diagnosis of dementia or SLUMS score \<20
* patient unable to communicate/cooperate/language barrier
* BMI\>40
* allergy to study medications
* opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day)
* other sources of chronic pain like fibromyalgia
* patients with associated significant CNS or respiratory disease (home oxygen requirements)
* incarcerated patients
* psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions
* pregnant or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05461092
Study Brief:
Protocol Section:
NCT05461092