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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT05881395
Eligibility Criteria:
Inclusion Criteria:
* ASA (American Society of Anesthesiologists) Physical Status Classification II or III
* Patients admitted to labour and delivery unit at Mount Sinai Hospital in their first stage of labour
* Patients who have a labour epidural that has been initiated as an epidural, CSE (combined spinal epidural) or a dural puncture epidural (DPE).
* Patients who are experiencing pain, defined as Visual Numerical Rating Score of more than 1/10, despite our institution's standard epidural Programmed Intermittent Epidural Bolus maintenance regimen and request a manual epidural top-up for the first time
* Have capacity to consent to the study
Exclusion Criteria:
* Patients with a language barrier that may interfere with accurate response to sensory block assessment
* Patients with medical conditions that would compromise sensitivity to cold or pinprick assessments
* patients who sustained unintentional dural puncture, those requiring change in our standard epidural maintenance regimen or those who have had a failed epidural requiring replacement.
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05881395
Study Brief:
Protocol Section:
NCT05881395