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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT00443404
Eligibility Criteria:
Inclusion Criteria:
* Age \>18, Visual Analog. Scale (VAS) pain score \>70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent.
Exclusion Criteria:
* No written patient consent
* Age \< 18 years
* Age \> 82 years
* Antiplatelet medication
* Mental status not acceptable
* Exclusion criteria were age \>85
* Emergency amputation
* Ipsilateral re-amputation
* Foot or toe amputation
* Inability to complete a detailed pain questionnaire
* History of chronic pain or substance abuse
* Active psychiatric disease requiring treatment
* Any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT00443404
Study Brief:
Protocol Section:
NCT00443404