Labor Epidural AnalgesiaNCT07831967
Perfusion Index Variability During Epidural Labor Analgesia
An observational study of Labor Epidural Analgesia and Perfusion Index, run by Medical University of Gdansk at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Epidural Analgesia, Perfusion Index, Pain
- What is being tested?
- Epidural (or opioid-only combined spinal-epidural) labor analgesia
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 15 Sep 2026to 31 Oct 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Use of epidural analgesia (epidural block, or combined spinal-epidural block) during spontaneous vaginal delivery.
- Signed informed consent to participate in the study.
Who cannot join
- Administration of local anaesthetic into the intrathecal (subarachnoid) space as part of combined spinal-epidural analgesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
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, 80-322
Tomasz Jasiński, MD PhD, +48 349 32 80, tjasinski@uck.gda.pl
About this study
Official title: Variability of the Peripheral Perfusion Index (PI) During Epidural Analgesia for Labor: A Single-Centre Prospective Observational Study
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.
Read the 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.
Additional clinical data: Ramsay sedation score; correct block function assessed by cold sensation test; pain intensity on the Numeric Rating Scale (NRS); motor block on the Bromage scale; stage of labor and cervical dilation; body position; and any need to adjust catheter depth or replace the catheter. When reported pain exceeds NRS 4, pain location is additionally recorded. Intravenous drugs and fluids (dose and time), obstetric data (operative vaginal delivery with forceps or vacuum, episiotomy, conversion to caesarean section) and basic demographics (age, gestational week, number of previous pregnancies) are recorded, together with relevant comorbidities and medications to allow later subgroup analyses. Data are archived on a dedicated form or in the patient's anaesthesia chart.
Recording duration: Recording runs from before placement of the regional block until 30 minutes after delivery. If delivery is completed by caesarean section, recording continues until the patient is transferred to the operating room.
Non-invasive nature and standard of care: All recorded parameters are obtained non-invasively. PI - the study's object of interest - is recorded with the pulse oximeter that forms part of standard monitoring of patients receiving regional labor analgesia. The scope and frequency of monitoring are consistent with the applicable Polish organisational standard of perinatal care and with the procedures of the University Clinical Centre in Gdańsk.
- Conditions
- Labor Epidural Analgesia, Perfusion Index, Pain
- Being tested
- Epidural (or opioid-only combined spinal-epidural) labor analgesia
- Keywords
- Epidural Analgesia, Combined Spinal-Epidural, Pulse Oximetry, Photoplethysmography, Labor, Perfusion Index, Obstetric Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural (or opioid-only combined spinal-epidural) labor analgesiaOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Epidural (or opioid-only combined spinal-epidural) labor analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From before neuraxial block placement until 30 minutes after delivery (typically up to several hours of labor).
Secondary outcomes (4)
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
Measured: From before neuraxial block placement until 30 minutes after delivery.
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 (%)
Measured: From before neuraxial block placement until 30 minutes after delivery.
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 (%)
Measured: From before neuraxial block placement until 30 minutes after delivery.
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 (%)
Measured: From before neuraxial block placement until 30 minutes after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Epidural AnalgesiaStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Jasiński, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831967
- Sponsor's protocol ID
- OI-EPI-1
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability of the Peripheral Perfusion Index (PI) During Epidural Analgesia for Labor: A Single-Centre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07831967
- Acronym / sponsor ID
- OI-EPI-1
- Conditions
- Labor Epidural Analgesia, Perfusion Index, Pain
- Keywords
- Epidural Analgesia, Combined Spinal-Epidural, Pulse Oximetry, Photoplethysmography, Labor, Perfusion Index, Obstetric Analgesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Additional clinical data: Ramsay sedation score; correct block function assessed by cold sensation test; pain intensity on the Numeric Rating Scale (NRS); motor block on the Bromage scale; stage of labor and cervical dilation; body position; and any need to adjust catheter depth or replace the catheter. When reported pain exceeds NRS 4, pain location is additionally recorded. Intravenous drugs and fluids (dose and time), obstetric data (operative vaginal delivery with forceps or vacuum, episiotomy, conversion to caesarean section) and basic demographics (age, gestational week, number of previous pregnancies) are recorded, together with relevant comorbidities and medications to allow later subgroup analyses. Data are archived on a dedicated form or in the patient's anaesthesia chart.
Recording duration: Recording runs from before placement of the regional block until 30 minutes after delivery. If delivery is completed by caesarean section, recording continues until the patient is transferred to the operating room.
Non-invasive nature and standard of care: All recorded parameters are obtained non-invasively. PI - the study's object of interest - is recorded with the pulse oximeter that forms part of standard monitoring of patients receiving regional labor analgesia. The scope and frequency of monitoring are consistent with the applicable Polish organisational standard of perinatal care and with the procedures of the University Clinical Centre in Gdańsk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women receiving epidural labor analgesia | – | Other: Epidural (or opioid-only combined spinal-epidural) labor analgesiaPatients in spontaneous or induced vaginal labor receiving epidural analgesia as the sole regional technique, or combined spinal-epidural analgesia with intrathecal opioid only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- Use of epidural analgesia (epidural block, or combined spinal-epidural block) during spontaneous vaginal delivery.
- Signed informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Administration of local anaesthetic into the intrathecal (subarachnoid) space as part of combined spinal-epidural analgesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural (or opioid-only combined spinal-epidural) labor analgesiaNeuraxial 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). | Other | Women receiving epidural labor analgesia |
Primary outcome
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.
4 secondary outcomes
Correlation between Perfusion Index change and pain intensity (NRS
Time frame: From before neuraxial block placement until 30 minutes after delivery.
Change in Perfusion Index associated with catheter malposition
Time frame: From before neuraxial block placement until 30 minutes after delivery.
Change in Perfusion Index associated with sacral sparing in the second stage of labor
Time frame: From before neuraxial block placement until 30 minutes after delivery.
Perfusion Index across maternal body positions during epidural labor analgesia
Time frame: From before neuraxial block placement until 30 minutes after delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Labor Epidural Analgesia
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Not yet recruitingObservational study
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
Not yet recruitingPhase 4
Does the Volume of Medication Affect the Success of Labor Epidural Analgesia
Labor Pain and to Reduce Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Epidural Analgesia and Perfusion Index, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Jasiński, MD PhD (+48 58 349 32 80, tjasinski@uck.gda.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.