Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07831967

Perfusion Index Variability During Epidural Labor Analgesia

Sponsor: Medical University of Gdansk

View on ClinicalTrials.gov

Summary

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.

Official title: Variability of the Peripheral Perfusion Index (PI) During Epidural Analgesia for Labor: A Single-Centre Prospective Observational Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-09-15

Completion Date

2027-10-31

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

OTHER

Epidural (or opioid-only combined spinal-epidural) labor analgesia

Neuraxial labor analgesia administered as part of routine care; local anaesthetic ± opioid via the epidural catheter (bolus and/or infusion), with exact drugs, doses, concentrations, volumes, infusion rates and times recorded. In the CSE subgroup only intrathecal opioid is given (intrathecal local anaesthetic is excluded).

Locations (1)

University Clinical Centre in Gdańsk , Drpartment of Anesthesiology nd Intensive Therapy and Department of Obstetrics and Gynaecology, Gynaecologic Oncology and Gynaecologic Endocrinology

Gdansk, Pomeranian Voivodeship, Poland