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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT04068766
Eligibility Criteria:
Inclusion Criteria:
* Uterine myoma
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* The absence of pregnancy at the time of surgery.
Exclusion Criteria:
* history of cervical surgery such as conization or cerclage
* inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix)
* allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection
* any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedure (anterior or posterior colporrhaphy or mid-urethral slings)
* previously taking opioids for chronic pain
* inability to accurately express their pain
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04068766
Study Brief:
Protocol Section:
NCT04068766