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 @ 2:45 PM
Ignite Modification Date:
2025-12-24 @ 2:45 PM
NCT ID:
NCT05590559
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18 years of age or older)
* ASA I-III
* Patients scheduled for elective unilateral mastectomy followed by direct reconstruction
* Ability to give written and oral informed consent
Exclusion Criteria:
* Patient refusal
* Non-elective surgery
* Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease )
* Allergy to amide-linked local anesthetics
* Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block)
* Severe spinal malformations or history of extensive spine surgery - A history of spinal cord injury
* Known psychiatric disorder
* Chronic pain patients or patients already using opioids pre-operatively
* Infection of the skin at the site of needle puncture area - Inability to give oral and written informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05590559
Study Brief:
Protocol Section:
NCT05590559