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Clinical Trials/NCT07831967
NCT07831967Not yet recruitingNot Applicable

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

Medical University of Gdansk1 site in 1 country200 target enrollmentStarted: September 15, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
200
Locations
1
Primary Endpoint
Change in peripheral Perfusion Index (PI) during epidural labor analgesia

Study Overview

Brief 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.

Detailed Description

Background: The Perfusion Index (PI) is the ratio of the pulsatile (AC) to the non-pulsatile (DC) component of light absorption in the photoplethysmographic waveform recorded during pulse oximetry, expressed as a percentage. Originally used as an indicator of pulse-oximeter signal quality, PI is now recognised as a non-invasive measure of peripheral perfusion. Because both signal components are influenced chiefly by vascular tone and vascular-bed filling, PI changes across clinical states. Spontaneous vaginal labor involves changes in cardiac output, peripheral resistance and blood redistribution, and therefore in PI. Neuraxial (epidural) analgesia further modifies PI: the sympathetic block it produces causes vasodilation and compensatory changes in peripheral resistance in non-blocked regions, altering peripheral perfusion. These changes can be captured systemically by the finger pulse oximeter routinely used to monitor labor analgesia. Analysing PI during epidural monitoring may therefore provide clinically useful information about correct block placement, drug distribution in the epidural space across successive stages of labor, and thus analgesic effectiveness.

Design and population: Prospective observational study. Participants are patients admitted to the labor ward of the Department of Obstetrics and Gynaecology, Gynaecologic Oncology and Gynaecologic Endocrinology, University Clinical Centre in Gdańsk, who receive epidural analgesia during vaginal delivery - either as the sole regional technique or as combined spinal-epidural (CSE) analgesia. For CSE, only intrathecal opioids may be administered (the standard approach in these patients); intrathecal local anaesthetic is an exclusion criterion. Both spontaneous-onset and induced labors are eligible.

Recorded haemodynamic parameters: PI is recorded automatically together with peripheral oxygen saturation (SpO2). Additional parameters recorded with standard monitors are arterial blood pressure, maternal heart rate (HR) and fetal heart rate (FHR). Monitoring begins before placement of the regional block.

Measurement schedule: Parameters are recorded every 5 minutes for the first 30 minutes after administration of local anaesthetic (LA) into the epidural space, and every 15 minutes thereafter. When bolus LA doses are given into the epidural space, 5-minute recording is resumed for 30 minutes from the time of administration. Data are archived as printouts from the labor-ward telemetry system.

Regional block data: The type of block and the doses/volumes and concentrations of all administered drugs are recorded with exact times. For drugs given by infusion, the flow rate per unit time and the time range for each rate are recorded.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Use of epidural analgesia (epidural block, or combined spinal-epidural block) during spontaneous vaginal delivery.
  • Signed informed consent to participate in the study.

Exclusion Criteria

  • Administration of local anaesthetic into the intrathecal (subarachnoid) space as part of combined spinal-epidural analgesia.

Arms & Interventions

Women receiving epidural labor analgesia

Patients in spontaneous or induced vaginal labor receiving epidural analgesia as the sole regional technique, or combined spinal-epidural analgesia with intrathecal opioid only.

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

Outcomes

Primary Outcomes

Change in peripheral Perfusion Index (PI) during epidural labor analgesia

Time Frame: From before neuraxial block placement until 30 minutes after delivery (typically up to several hours of labor).

Peripheral Perfusion Index (%), recorded non-invasively from a finger pulse oximeter, tracked across the course of labor. PI is recorded before block placement and then every 5 minutes for the first 30 minutes after epidural local-anaesthetic administration, every 15 minutes thereafter, with 5-minute recording resumed for 30 minutes after each epidural bolus. The pattern and magnitude of PI change relative to the pre-block baseline are assessed.

Secondary Outcomes

  • Correlation between Perfusion Index change and pain intensity (NRS(From before neuraxial block placement until 30 minutes after delivery.)
  • Change in Perfusion Index associated with catheter malposition(From before neuraxial block placement until 30 minutes after delivery.)
  • Change in Perfusion Index associated with sacral sparing in the second stage of labor(From before neuraxial block placement until 30 minutes after delivery.)
  • Perfusion Index across maternal body positions during epidural labor analgesia(From before neuraxial block placement until 30 minutes after delivery.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tomasz Jasiński

Assistant proffesor, MD, PhD

Medical University of Gdansk

Study Sites (1)

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