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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT01014520
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent
* Age:18 to 60
* Weight: 60 to 80 Kg
* ASA Class: I,II
* Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
* Single level lumbar disk herniation unresponsive to medical treatment
Exclusion Criteria:
* Previous consumption of Gabapentin or Amitriptyline
* Known allergy to investigated drugs
* Reluctant to sign informed consent
* Previous history of intolerance to narcotics
* Simultaneous lumbar diskectomy and a fusion technique
* Known renal failure
* Pregnancy
* Contraindications to Amitriptyline or Gabapentin prescription
* Unable to use PCA
* Habitual use of alcohol or opium
* History of analgesic consumption during the last 24hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01014520
Study Brief:
Protocol Section:
NCT01014520