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Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.

Prospective Observational Study: Ultrasound Predictors of Difficulty in Performing Epidural Anesthesia for Labor in Pregnant Patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07056166
Enrollment
563
Registered
2025-07-09
Start date
2025-08-13
Completion date
2027-07-31
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Catheterization

Keywords

Epidural analgesia, Pregnancy, Spinal ultrasound, Difficult epidural, Obstetric anesthesia

Brief summary

This is a prospective observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Pregnant women who request epidural analgesia will undergo a quick ultrasound scan of their lower back before the procedure. The study will collect information such as age, weight, height, and spinal anatomy, as well as ultrasound measurements. This information will be compared with how easy or difficult it was to place the epidural. The study does not involve any experimental treatment and uses standard care procedures already in place. There are no additional risks or costs for participants.

Detailed description

This is a single-center, prospective observational study aimed at evaluating whether specific ultrasound measurements of spinal structures in pregnant women can predict technical difficulty in placing an epidural catheter during labor analgesia. All procedures performed are part of standard care and are routinely offered in the labor and delivery unit. Patients who consent to participate will undergo a lumbar ultrasound prior to epidural catheter placement. Data will be collected regarding anatomical and clinical characteristics, ultrasound findings, and procedural details. The study will run for two years or until the estimated sample size of 563 patients is reached. The results are intended to identify non-invasive predictors of challenging epidural placement, potentially improving patient safety and resource allocation.

Interventions

Epidural catheter placement for labor analgesia

PROCEDUREspine ultrasonography

An ultrasound scan will be performed on the spine to identify anatomical characteristics of potential interest

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-Inclusion Criteria: Pregnant women aged ≥18 years Candidates for epidural catheter placement for labor analgesia Provided written informed consent

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Difficulty of epidural catheter placementPeriproceduralDefined as the need for more than one puncture attempt (exiting the skin with the needle) or the involvement of a second operator to successfully place the epidural catheter.

Secondary

MeasureTime frameDescription
Number of puncture attemptsPeriproceduralNumber of attempts required to successfully insert the epidural catheter.
(Predictor of difficult Epidural) Distance from skin to spinous process at epidural placement levelPeriproceduralThe distance measured in cm between the skin surface and the spinous process at the intended epidural insertion site, assessed using ultrasound scanning.
(Predictor of difficult Epidural) Distance between spinous processesPeriproceduralMeasured in centimeters by ultrasound to assess interspinous space width.
(Predictor of difficult Epidural) Distance from skin to transverse processPeriproceduralMeasured in centimeters by ultrasound to assess distance between skin and transverse process.
(Predictor of difficult Epidural) Patient ageBaselineMeasured in years
(Predictor of difficult Epidural) Previous spinal surgeryBaselineYes or No variable. Accounting for any type of vertebral surgery
(Predictor of difficult Epidural) Current weightBaselineMeasured in kg
(Predictor of difficult Epidural) Body Mass Index (BMI)BaselineMeasured in kg/cm2
(Predictor of difficult Epidural) Palpability of spinous processesPeriproceduralMeasured as Yes, Not completely, No
(Predictor of difficult Epidural) Presence of scoliosisBaselineYes or No variable.
(Predictor of difficult Epidural) Operator ExperiencePeriproceduralOperator related. Defined as the number of epidural catheter previously positioned
(Predictor of difficult Epidural) Pre-pregnancy weightBaselineMeasured in kg

Countries

Italy

Contacts

Primary ContactAlessandro De Cassai, Medical Doctor
alessandro.decassai@aopd.veneto.it+390498213090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026