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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07436403
Eligibility Criteria:
Inclusion Criteria:
* Both gender (male and female) aged between 18 and 65.
* Adults undergoing elective orthopedics or urology procedures planned under spinal anesthesia.
* ASA status I or II.
* Ability to give informed consent and comply with postoperative assessment.
Exclusion Criteria:
* Any contraindication to spinal anesthesia, including infection at puncture site, coagulopathy or therapeutic anticoagulation, thrombocytopenia, severe hypovolemia or shock, raised intracranial pressure due to space occupying lesion, or suspected spinal canal infection.
* Known hypersensitivity to planned intrathecal local anesthetic or adjuvant drugs.
* History of chronic daily headache, migraine requiring regular prophylaxis, or headache at baseline on the day of surgery.
* Prior lumbar spine surgery, significant spinal deformity, or neurological disease affecting lower limb sensation that will interfere with neuraxial assessment.
* Inability to complete follow-up assessments due to impaired cognition, severe psychiatric illness, or major communication barrier.
* Emergency procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07436403
Study Brief:
Protocol Section:
NCT07436403