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

This study is currently recruiting participants.
Verified May 2012 by Università degli Studi dell'Insubria
Sponsor:
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01438099
First received: September 14, 2011
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:
  • The congruity between palpatory technique and ultrasound lumbar evaluation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    The congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space performing epidural analgesia


Secondary Outcome Measures:
  • Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients will be measured and compared to the needle depth


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • all women who request epidural analgesia for labor

Exclusion Criteria:

  • all women who present contraindication for epidural analgesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438099

Contacts
Contact: Paolo MD Severgnini, Prof. 0039-0332-278801 paolo.severgnini@uninsubria.it
Contact: Antonio MD Ceron, Dr. 0039.0332.274111 cerant@libero.it

Locations
Italy
Azienda ospedaliera ospedale Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Contact: Paolo MD Severgnini, Prof.     0039-0332-278801     paolo.severgnini@uninsubria.it    
Sub-Investigator: Antonio MD Ceron, Dr.            
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Paolo Severgnini, Prof. Universita' degli Studi dell'Insubria, Varese, Italy
  More Information

No publications provided

Responsible Party: Paolo Severgnini, Prof., Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01438099     History of Changes
Other Study ID Numbers: 18894
Study First Received: September 14, 2011
Last Updated: May 30, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Università degli Studi dell'Insubria:
epidural analgesia
ultrasound
labor analgesia
labor

ClinicalTrials.gov processed this record on May 16, 2013