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Perfusion Index Variability During Epidural Labor Analgesia

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
This prospective, single-centre observational study evaluates changes in the peripheral Perfusion Index (PI) - a non-invasive parameter derived from the pulse-oximetry photoplethysmographic waveform - in women receiving epidural, or combined spinal-epidural (CSE) with intrathecal opioid only, analgesia during vaginal labor. Epidural-induced sympathetic block causes vasodilation and compensatory changes in peripheral vascular resistance, which alter peripheral perfusion and therefore PI. PI is recorded together with routinely monitored haemodynamic, obstetric and analgesia-related variables (including pain intensity on the Numeric Rating Scale, NRS) from before block placement until after delivery. The aims are: to describe the pattern and magnitude of PI changes during labor analgesia and the parameter's usefulness in this dynamic clinical setting; to assess the correlation between PI changes and reported pain; and to evaluate whether PI (its change or the absence of change) can help identify ineffective blocks early - for example those caused by catheter malposition or by sacral sparing in the second stage of labor. All measurements are non-invasive and consistent with the current standard of perinatal care.
Trial Details
NCT Number NCT07831967
Lead Sponsor Medical University of Gdansk
Conditions
(from sponsor)
Labor Epidural Analgesia, Perfusion Index, Pain
Related terms Pain
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov