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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01438099
First received: September 14, 2011
Last updated: August 23, 2013
Last verified: August 2013
  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:


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


Enrollment: 300
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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

Locations
Italy
Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Varese, Italy, 21100
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: August 23, 2013
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 April 17, 2014