跳至主要内容
临床试验/NCT07831967
NCT07831967尚未招募不适用

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

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Change in peripheral Perfusion Index (PI) during epidural labor analgesia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Epidural (or opioid-only combined spinal-epidural) labor analgesia (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Jasiński

Assistant proffesor, MD, PhD

Medical University of Gdansk

研究点 (1)

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