Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

Study Overview

• Status: Completed
• Conditions: Pregnancy

Detailed Description

This study has four specific aims:

1. to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space;
2. to compare between ultrasound evaluation and needle measure of skin-epidural space depth;
3. to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients;
4. to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy, 21100
    • Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor

Description

Inclusion Criteria:

• all women who request epidural analgesia for labor

Exclusion Criteria:

• all women who present contraindication for epidural analgesia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
normal subjects; parturients admitted to the labor ward who request epidural analgesia with BMI < 30
obese subjects; parturients admitted to the labor ward who request epidural analgesia with BMI > 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The congruity between palpatory technique and ultrasound lumbar evaluation	The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia	participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients	Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients will be measured and compared to the needle depth	participants will be followed for the duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Paolo Severgnini, Prof., Universita' degli Studi dell'Insubria, Varese, Italy

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: ultrasound; epidural analgesia; labor; labor analgesia
• Other Study ID Numbers: 18894