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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438099
• Other study ID #: 18894
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: August 23, 2013
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• all women who request epidural analgesia for labor

Exclusion Criteria:

• all women who present contraindication for epidural analgesia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
Italy	Azienda ospedaliera ospedale Circolo e Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No