Perfusion Index Variability During Epidural Labor Analgesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMedical University of Gdansk
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Use of epidural analgesia (epidural block, or combined spinal-epidural block) during spontaneous vaginal delivery.
Signed informed consent to participate in the study.
Disqualifiers
None
Trial population
Women in spontaneous or induced vaginal labor, 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 or opioid-only combined spinal-epidural analgesia.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Epidural (or opioid-only combined spinal-epidural) labor analgesia
Other interventionNeuraxial 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).
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Women receiving epidural labor analgesia1 intervention
Trial outcomes
Primary outcomes
1
Change in peripheral Perfusion Index (PI) during epidural labor analgesia
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.
Time frame
From before neuraxial block placement until 30 minutes after delivery (typically up to several hours of labor).Secondary outcomes
1
Correlation between Perfusion Index change and pain intensity (NRS
Association between changes in PI and self-reported pain intensity on the Numeric Rating Scale (NRS, 0-10) during epidural labor analgesia. NRS ≤ 4 is regarded as acceptable analgesia; pain location is additionally recorded when NRS \> 4. Unit of Measure : repeated-measures correlation coefficient
Time frame
From before neuraxial block placement until 30 minutes after delivery.2
Change in Perfusion Index associated with catheter malposition
Magnitude of the change in PI (%) around events of epidural catheter malposition. Malposition is identified clinically by the need for catheter depth adjustment or replacement. Unit of Measure - Perfusion Index (%)
Time frame
From before neuraxial block placement until 30 minutes after delivery.3
Change in Perfusion Index associated with sacral sparing in the second stage of labor
Magnitude of the change in PI (%) in cases of sacral sparing, identified clinically by inadequate sacral analgesia in the second stage of labor (cold sensation test and NRS \> 4 in the sacral distribution). Unit of Measure - Perfusion Index (%)
Time frame
From before neuraxial block placement until 30 minutes after delivery.4
Perfusion Index across maternal body positions during epidural labor analgesia
Peripheral Perfusion Index (%) recorded in the maternal body positions adopted during labor (e.g., supine with lateral tilt, lateral decubitus, sitting), to describe the effect of body position on PI. Unit of Measure - Perfusion Index (%)
Time frame
From before neuraxial block placement until 30 minutes after delivery.Sponsors and contacts
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Source ClinicalTrials.gov
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